335 Process Validation Jobs

Your future role Take on a new challenge and apply your **manufacturing engineering and process optimization** expertise in a cutting-edge field. Youll work alongside **collaborative and innovative** teammates. You'll play a key role in defining and optimizing manufacturing processes and equipment for new products, ensuring alignment with Alstoms industrial policies, standards, and project constraints. Day-to-day, youll work closely with teams across the business (such as Process Engineers, Manufacturing Engineers, and APSYS Leaders), collaborate with external stakeholders (including Product Design Engineers and Supply Chain teams), and contribute to continuous improvement initiatives. Youll specifically take care of **industrial documentation, process validation, and line balancing**, but also **support production teams in achieving QCD (Quality, Cost, Delivery) targets**. Well look to you for: Gathering and communicating industrial requirements to Engineering teams during product specification and design phases. Participating in co-engineering efforts to ensure manufacturability and alignment with industrial standards. Designing macro-processes and preparing the introduction of new technologies, including validation plans. Developing specifications for manufacturing equipment and workstation layouts while adhering to ergonomic and EHS rules. Completing industrial documentation, including Industrial Maturity Follow-Up (IMFU) and Process FMEA (P-FMEA). Validating product design and industrialization through FAR (First Article Review) and FAI (First Article Inspection). Supporting production teams post-serial Go with engineering changes, workstation updates, and QCD targets. Contributing to R&D programs and providing expertise in industrial costing during tender phases. Performing industrial REX (Return on Experience) to drive continuous improvement in manufacturing processes. All about you We value passion and attitude over experience. Thats why we dont expect you to have every single skill. Instead, weve listed some that we think will help you succeed and grow in this role: Technical education with proficiency in English (read, written, spoken). 5 to 10 years of experience in manufacturing or manufacturing engineering, preferably in the railway industry. Technical expertise in process engineering, writing manufacturing work instructions, line balancing, and lean manufacturing principles. Experience with ERP systems (e.g., SAP) for Bill of Materials, routings, and configuration follow-up. Knowledge of CAD and PLM tools (e.g., CATIA, DELMIA). Familiarity with quality standards, EHS regulations, ergonomics, and Process FMEA/QRQC methodologies. Proficiency in IT tools like MS Office (Word, Excel, PowerPoint). Strong communication skills, self-motivation, and a logical, organized approach to work.

Role & responsibilities The Engineering Manager will direct and coordinate all engineering activities within the company's flagship pharmaceutical manufacturing facility, including equipment maintenance, project management, and process validations to ensure overall plant goals and objectives are accomplished. Being the Lead Manufacturing Engineer for the Engineering Department, ensuring best practice processes are developed. Providing Manufacturing Engineering support to both customers and suppliers Identifying and implementing improvements to equipment, processes and methods Identifying and driving improvement initiative to reduce costs and improve on time delivery Provide technical assistance to the engineering team to ensure equipment issues are addressed Assure proper documentation of technical data generated for the assigned projects and/or tasks consistent with engineering policies and procedures Maintain accurate and secure records for all engineering maintenance activities performed and to ensure that they are performed as per schedule

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 10 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.

This Position reports to: Production Manager Your role and responsibilities You will be working as Quality Control Specialist look after Consistency and quality are top priorities for any manufacturer. But even with standards and specifications in place for employees to follow, businesses depend on quality engineers to verify that those standards are always met and that only the best products make it to market. The work model for the role is: #Li-Onsite This role is contributing to the ABB India, Smart Power, as a Quality Control Specialist for Nelamangala Bangalore Location. You will be mainly accountable for: Safety & Compliance: Assess risks, ensure safety for people and equipment, verify torque and equipment calibration, and maintain conformance with quality and production requirements. Process Validation & Improvement: Participate in production test system validation, identify improvement opportunities, implement projects, and apply APQP for new product introduction. Customer & Team Support: Resolve customer issues, support factory acceptance testing, and provide quality training to local teams for efficient and controlled processes. Control & Effectiveness: Help teams apply effective process management systems, implement internal controls, and ensure control plans mitigate risks. Qualifications for the role: Education: Bachelors degree in electrical/Electronic Engineering (mandatory) or related field. Experience: Minimum 5 years of quality experience in a manufacturing environment. Leadership: Prior supervisory experience. Technical Skills: Knowledge of electrical/mechanical testing, troubleshooting, or electronics assembly; familiarity with ISO 9001:2015, IEEE, UL, IEC 60947, EN 62040-3, and SAP. Testing Proficiency: Familiarity with calibration and test equipment, handling non-conforming materials, conducting layout testing, ensuring wire continuity, performing HiPot (HV) tests, calculating CT ratios, and analyzing power quality. Product Knowledge: Experience with low voltage switchgear products. Process Focus: Exposure to process and industrial environments with a process improvement mindset.

We are seeking a Credit Risk Model Development expert to join our team. The ideal candidate will have extensive experience in building or validating sophisticated credit risk models. This role requires a strong analytical mind, proficiency in various programming languages, and a deep understanding of regulatory frameworks. Roles & Responsibilities Credit Risk Model Development & Validation: Develop or validate credit risk models , including those for IFRS9, IRB, CCAR, and CECL . Apply expertise in methodologies for Probability of Default (PD) , Loss Given Default (LGD) , Exposure At Default (EAD) , and Stress Testing . Technical Implementation: Utilize statistical and programming tools such as SAS, SQL, Python, and R . Analysis & Reporting: Conduct in-depth analysis of model performance and provide recommendations. Ensure models adhere to industry best practices and regulatory standards. Required Candidate Profile Experience: Mandatorily experienced in Credit Risk Model Development or Validation . Technical Skills: Skilled in SAS, SQL, Python, and R . Education: An MBA in Finance is preferred. Certifications like FRM or CFA are a significant plus. Additional Information Salary: Depends on the last drawn salary. Notice Period: Immediate joiners to those with a 30-day notice period. Work Arrangement: 5 days Work From Office (WFO) in an ODC setup. How to Apply To apply, please send your CV to: [HIDDEN TEXT] .

We are seeking a Credit Risk Specialist to join our team. The ideal candidate is a highly skilled professional with expertise in Credit Risk Model Development or Validation . This role requires strong analytical skills and proficiency in various programming languages to build and validate financial models. Roles & Responsibilities Credit Risk Modelling: Develop or validate credit risk models, including those for IFRS9, IRB, CCAR, DFAST, and CECL . Utilize a deep understanding of concepts such as PD (Probability of Default) and LGD (Loss Given Default) . Technical Skills: Apply expertise in statistical and programming tools like SAS, SQL, Python, and R . Analysis & Validation: Conduct in-depth analysis to ensure the accuracy and effectiveness of risk models. Required Candidate Profile Experience: We are hiring for two experience levels: 2-5 years and 5-8 years . Education: An MBA in Finance is required. Certifications like FRM or CFA are preferred. Technical Skills: Proven experience with SAS, SQL, Python, and R . Expertise: A background in Credit Risk Model Development or Validation is a must. Additional Details Salary: Up to ?27 LPA for 2-5 years of experience. Up to ?35 LPA for 5-8 years of experience. Notice Period: Immediate to 30 days . Work Schedule: 11:30 AM to 8:00 PM, with 5 days Work From Office (WFO) . How to Apply Please send your CV to [HIDDEN TEXT] or contact 9027310680 .

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Your future role Take on a new challenge and apply your manufacturing process expertise in a cutting-edge field. Youll work alongside collaborative and innovative teammates. You'll help shape the manufacturing process and ensure its alignment with industrial policies and project constraints. Day-to-day, youll work closely with teams across the business (Engineering, Production, and Quality), develop industrial documentation, and enhance production efficiency through process validation and optimization. Youll specifically take care of defining workstation layouts and performing line balancing, but also support production teams in achieving manufacturing Quality, Cost, and Delivery (QCD) targets. Well look to you for: Gathering and explaining industrial requirements to Engineering during product specification and design phases Designing macro-processes and preparing for the introduction of new technologies Completing industrial documentation, including Industrial Maturity Follow-Up (IMFU) and Process Failure Mode and Effects Analysis (P-FMEA) Validating product design and industrialization through First Article Review (FAR) and First Article Inspection (FAI) Defining and optimizing workstation layouts while adhering to ergonomic and EHS (Environment, Health, and Safety) standards Providing expertise during tender phases and contributing to R&D programs as an industrial representative All about you We value passion and attitude over experience. Thats why we dont expect you to have every single skill. Instead, weve listed some that we think will help you succeed and grow in this role: Technical education Experience or understanding of manufacturing or manufacturing engineering, preferably with 5-10 years in the railway industry Knowledge of process engineering, lean manufacturing, and line balancing Familiarity with ERP systems (such as SAP) and PLM tools (e.g., CATIA, DELMIA) A strong understanding of Quality, EHS standards, and ergonomics Proficiency in English (read, written, and spoken) Good communication, self-motivation, and a logical, organized approach

You'll define manufacturing processes and associated equipment for new products, ensuring alignment with industrial policies and project constraints. Day-to-day, youll work closely with internal teams like Product Design Engineers, Manufacturing, Sourcing, Supply Chain, and Industrial Quality, as well as external stakeholders such as central teams and other site Industrial Data Managers. Youll also lead a team to drive and execute projects, ensuring industrial deliverables are met on time. Youll specifically take care of creating industrial documentation, estimating manufacturing workloads, and validating product designs through FAR and FAI, but also support production in achieving manufacturing QCD (Quality, Cost, Delivery) targets. Well look to you for: Gathering industrial requirements and ensuring Engineering complies during product specification and design. Participating in co-engineering activities to design processes and introduce new technologies. Developing specifications for industrial means and defining workstation layouts adhering to ergonomic and EHS rules. Performing P-FMEA and macro-process design, including line balancing and process validation. Leading validation of prototypes and ensuring smooth transition to serial production. Supporting production teams post-serial Go and managing retrofit industrialization after engineering changes. Providing expertise to the Industrial Costing Manager during tenders and participating in R&D programs. Driving continuous improvement through industrial REX (Return of Experience). All about you We value passion and attitude over experience. Thats why we dont expect you to have every single skill. Instead, weve listed some that we think will help you succeed and grow in this role: Engineering degree in Mechanical or Electrical fields. 8-10 years of experience in manufacturing or manufacturing engineering, preferably in the railway or automobile industry. Technical expertise in process engineering, writing manufacturing instructions, line balancing, and Lean Manufacturing. Experience working with ERP systems (e.g., SAP) for Bill of Materials, Routings, and Configuration follow-up. Knowledge of CAD and PLM tools (e.g., CATIA, DELMIA). Familiarity with IS tools, Process FMEA, and QRQC methodologies. Understanding of Quality, EHS standards, and Ergonomics. Strong leadership skills to manage a team and deliver industrial objectives.

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: We are looking for experienced Test automation engineers/SDETs who could join our cloud product engineering team to build the next gen applications for our global customers. If you are a technology enthusiast and have passion to develop and/or test enterprise cloud products considering quality, security, and performance, we are eager to discuss with you about the potential role. Responsibilities: Part of a team (BA/PO, Developers, SDETs etc) that develops enterprise software applications. Understand the business requirements and design, development/coding aspects. Participate in the complete development life cycle. Setup, Maintain and Operate test automation frameworks. Performing test automation on multiple application platforms ‚ Web, Mobile etc Create and Manage test repository (scenarios, cases, steps, priorities, categories etc), test metrics. Manage/Involve with CI/CD specific activities. Own and be accountable for the Quality, Reliability of the respective product deliverables. Strive for self-excellence along with enabling success of the team/stakeholders. 2 to 6 years of experience with enterprise software product development lifecycle/phases. Object oriented design and coding skills in any of the programming languages ‚ C#, Python, Javascript. Skilled in UI and API testing. Experience of building and implementing automation frameworks ‚ Preferably Robo/Python based Exposure to Agile, DevSecOps methodologies Ability to review the code, write unit tests, approach the test outcome with a programmer‚s mindset. Good understanding of distributed systems architecture, component layers, algorithms etc. Knowledge of Performance and Security testing tools/frameworks Requirements: 2 to 6 years of experience with enterprise software product development lifecycle/phases. Object oriented design and coding skills in any of the programming languages – Python, Javascript. Experience of building and implementing UI and API automation frameworks Exposure to Agile, DevSecOps methodologies Ability to review the code, write tests, approach the test outcome with a programmer’s mindset. Good understanding of distributed systems architecture, component layers, algorithms etc. Knowledge of Performance and Security testing tools/frameworks Experience/knowledge in pharma regulatory, quality, risk, process validation is preferable. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

Responsible for QA functions-legal documentation, Compliance of QA/ISO/EHS systems/insecticides rules, Analysis, Timely, accurate & cost effective analytical support to plant, preparing SOP/Verification of testing methods, Instruments calibration etc Required Candidate profile M.Sc.with 3 to 6 yrs relevant exp in Agrochemical industry. Knowledge of quality systems, in house calibration of lab instruments , handling of QA lab Instruments , Root Cause Analysis Techniques etc.

Job description Position : Assistant Manager - Technical Position Reports to : Direct Line : Senior Manager - Process & Product Improvement Dotted Line : General Manager Department : Technical & CIBB Location : Jigani, Bangalore India General Summary of Position : Reviewing organization&aposs operating mechanisms, test process effectiveness and ensure that outcome meets operating requirements in the short and long terms. Responsible for all process validation aspect within process improvement of NRL&PI Collaborate with production personnel, R&D and manufacturing Manager for production, NR & PI to control and improve operating processes via continuous improvement. To provide and improve technical capabilities in Operations. Provide technical support and assessment related to manufacturing, sourcing and continuous improvement of commercialized products and technologies in Lifestyle Global including change control and regulatory aspects as appropriate To execute projects assigned by Sr Manager Process and product Improvement in accordance to the Ops project time frames, budget allocations, and change control procedures. Assist Sr. Manager- Process and product Improvement, supervise and develop the skill base of process technician, supervisor and officer for process control, improvement and technical development to roll out continuous improvement for commercial production. Take steering role in the development of new process and manufacturing best practices for NRL,PI and Packing production. Implement Six Sigma methodology for process improvement and sustainable growth of the plant. Support, facilitate and leads strategic, high impact process improvement project. Deploys techniques of definition, measurement, analysis, improvement and control. Plans, coordinates, executes and performs process design tasks; collaborate closely with other department within ops and oversees project activities, such as process simulation and improvement to achieve the main objective. He/she also interacts with computer hardware and software; provides periodic data to supervisors; and establishes goals, plans and work schedules. The person in this position must coordinate and participate in every activities of safety, health, environment and report the unsafe act in order to minimize any injury occurred. Responsibilities & Specific Accountabilities Maintain compliance with Quality Management System Regulation. Maintain compliance with all internal and external EHS rules, regulations and other Risk Management requirements. Actively use the safety calendar (or contribute to the activities prescribed in HODs calendar) as an accountability tool to measure safety performance and to promote the development of a EHS culture. Maintain proper crisis management- and disaster response plans and execute regular drills in order to be prepared for proper and timely crisis responses. Establish objective, KPI & target, production and process problem solving, continuous product quality and process improvement. Shall manage all project within due time. Leadership in planning &Design validation/study, validation control and monitoring, Conclusion and finalize validation. Key Position Requirements Education Bachelors degree/masters degree. Rubber Technology / Science/Pharma /Industrial engineering /Chemical Engineer Job Experience At least 5 years working experience in rubber manufacturing/project management/Medical device/Pharma. Knowledge and Skills Technical knowledge (Rubber technology, mechanic), working Process and System Understanding, production knowledge and quality control knowledge Project management, Process validation, Problem solving Tool, Basis statistical knowledge, Innovative thinking, Analytical and Conceptual Thinking, Problem solving, Decision Making, Information seeking and clarifying. Performance and people management, Co-ordination and communication skill and Conflict management. Good command of spoken, written English, local language and computer skill Desirable Job Competencies Project and time management Design validation and process validation. Process trouble shooting Presentation skills Additional Requirements (Travel etc.) Training as needed About the Company LifeStyles has a history dating back to 1905 when Eric Ansell first started making condoms in Richmond Australia. Today LifeStyles is a Global leader in the sexual wellness sector, comprising a broad range of condoms, personal lubricants, and other related products and other products in over 60 countries. Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products either under leading global non-latex condom brands SKYN under its local heroes such as LifeStyles, Manix, Unimil, and Blowtex and Control. Outside of branded products, the Company also supports universities, NGOs, and other organizations as part of a broader effort to promote sexual health and prevent the spread of STDs and STIs. LifeStyles owns and operates manufacturing facilities in Thailand, India and Spain, and it employs over 1,600 teammates globally. LifeStyles Healthcare was created on September 1, 2017 , when the consortium of Humanwell Healthcare & CITIC Capital private equity purchased the Sexual Wellness division from Ansell. As of December 1, 2022, Lifestyles is owned by Linden Capital Partners , a Chicago-based private equity firm focused on the healthcare industry. This is an exciting time to join us. We combine century-long history with the opportunity of a new beginning as a stand-alone company - this means a new way of thinking, the opportunity to explore new horizons and the chance to make a mark in an exciting, fresh business. LifeStyles Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We are empowered professionals, and we are committed to creating a team of the worlds best of the best. Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged, and we are excited about a new phase in the company history. We have a focus on safety and teamwork - and we want you to join us! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Discover more about us at: https://www.linkedin.com/company/lifestyles-healthcare/. Curious to know what does every day look like at LifeStyles Find out by looking at employee testimonials: https://lifestylesglobal.com/careers Due to the high number of applications, we would like to inform you that only selected candidates will be contacted. Show more Show less

Perform line clearance activities prior to production operations. Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Batch Filling Records (BFR). Execute in-process QA checks and verifications during manufacturing and packaging. Manage control sample collection, storage, and documentation. Collect in-process, finished product, and customer complaint samples as required. Compile Annual Product Quality Review (APQR) data and perform trend analysis. Participate in process validation, hold time studies, and related quality activities. Coordinate with relevant departments for timely batch release. Conduct routine GMP checks in production, warehouse, and other relevant departments. Coordinate and review vendor management documents and compile vendor assessment reports. Manage document archival as and when required in compliance with applicable procedures. Issue and control formats, Standard Operating Procedures (SOPs), specifications, and batch records. Qualifications: B.Pharma/M.Pharma/M.Sc (Chemistry) Exp.- 5-10yrs

Preferred candidate profile 1. Expose to injection facility 2. Qualification of equipment 3. Process Validation 4. Media Fill 5. IPQA activity 6. QMS & other documentation

You should have a background in B.Pharma / M.Sc. and preferably from the Pharma industry. It is mandatory to have experience in both Sterile & Non-Sterile processes. Experience in Regulatory markets such as USFDA, MHRA, EU is required, with USFDA being the first preference. The offered CTC for this position is 30 LPA and a minimum of 15 years of experience is necessary. Both male and female candidates are welcome to apply. Your responsibilities will include having a strong understanding of Cleaning Validation, Process Validation, Equipment Qualification, and Computer System Validation. You will be in charge of managing 4 units within the Indore Site. Strong team management and communication skills are essential for this role.,

You will proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at the site by keeping track of quality metrics. You will ensure the site is always ready for regulatory/statutory inspections/internal audits and regularly monitor the performance of each individual in the Quality department. You will facilitate internal and regulatory agency audits, ensuring findings from site audits are understood, assessed, and addressed comprehensively. Moreover, you will ensure the closure of audit observations by reviewing the CAPA and driving its implementation. Implementation of requisite changes at the plant level as per global/local regulations will also be your responsibility. You are expected to escalate any Batch failure, Quality complaint, recall, critical observation, etc., to senior management. Providing leadership and direction to ensure the achievement of accountabilities for all Quality sub-functions at the site is crucial. You will ensure the timely update and approval of all master documents such as BMR, SOPs, Specifications, site master file, validation master plan, schedules, etc. It is essential to ensure that the validation system remains updated as per regulatory requirements and industry standards. Your responsibility will include the execution and review of Qualification/Re-Qualification and Validation activity of Equipment/System/Facility and Plant utilities. You will coordinate with manufacturing, Engineering, and QC personnel for respective Qualification/Validation/Re-qualification activity for the timely completion of activities. Additionally, you will prepare Standard Operating Procedures of the Quality Assurance Department and conduct risk assessment activities related to Equipment/Process/Facility/System. Ensuring timely release of manufactured batches by reviewing BMR/BPR and their compliance, in-process testing & timely release, and training and post-training evaluation of staff and workers will also fall under your responsibilities. Besides, you will review and approve documents like Validation protocols, reports, QRM, SOPs, etc., assess, review, and approve Change Control, Deviation, CAPA, Investigation, and approve URS, DQ, and vendor/suppliers documents related to qualification. Conducting Annual Product Quality Review, handling Market Complaint, Recall and Product Failure Investigation, and performing non-conformance investigations are also part of your duties. You are required to perform trend analysis of deviations to evaluate recurring problems and recommend CAPA if necessary, self-inspect different departments, review compliance/action plans against noted observations during self-inspection, and participate in Quality management review. Approval of Master Documents like specification, Method of Analysis, Stability Study report, SOP, and handling Vendor Qualification and Re-approval audit for RM, PPM, SPM, Contract analysis laboratory, and Contract services are also expected from you. Skills required for this role include Regulatory Compliance & Validation Guidelines Knowledge, Validation Master Plan Development & Execution, Process Validation, Cleaning Validation, Equipment Qualification (DQ, IQ, OQ, PQ), Environmental Monitoring & HVAC Qualification, Regulatory Inspections & Audit Readiness for Validation, Deviation Management, Change Management, In-Process Checks & Monitoring, and Batch Record Review. Education qualifications include B.Pharma, M.Sc., M.Pharma, with a total experience of 12 - 16 Years in a sterile manufacturing plant. Candidates applying for internal jobs must have completed at least 2 years within the existing role.,

As a Product Supply Manager at Procter & Gamble, you will have the opportunity to work with cutting-edge technologies and standards that are globally recognized. Your role will involve leading a team to identify and eliminate losses through process and organization capability development using manufacturing tools. You will also be responsible for standardization, equipment changes, process validation, and technical troubleshooting of process failures. On a daily basis, you will set the direction for the team, report results, address issues, and request necessary resources. Your focus will be on reducing costs, driving productivity projects, and optimizing asset utilization through benchmarking. You will also play a key role in coordinating capital projects across various functions and teams, as well as leading project management teams to control and optimize capital and project spending. In this role, you will have the opportunity to work on challenging manufacturing and engineering assignments in a dynamic and international work environment. Procter & Gamble offers not just a job, but a career with diverse assignments and ample development opportunities. You will have the chance to develop and deliver state-of-the-art technologies supported by significant capital investments, with travel opportunities to project locations to witness your designs in action. Continuous coaching and mentoring will be provided, enabling you to work with passionate individuals and receive both formal training and day-to-day guidance from your coach and manager. The company values every individual, promoting agility, work-life balance, and initiatives. Additionally, a competitive compensation package will be offered, tailored to your qualifications and experience.,

You will be responsible for performing In-Process Quality Assurance (IPQA) activities on the shop floor at every stage of manufacturing and packing processes. This includes ensuring QA standards for clean room behavior and activities, reviewing batch processing records, and checking all documents related to manufacturing, packaging, and analysis reports before batch release. You will also be required to review documents, logbooks, and conduct IPQA for Dispensing, Manufacturing, Packaging, and Dispatch activities. As part of your role, you will review and control Standard Operating Procedures (SOPs), specifications, Batch Production Records (BPR) issuance, Master Formulae, and records. Additionally, you will be involved in the preparation and review of process validation protocols and reports. In the absence of an authorized person, you may also be required to execute validation/revalidation activities. Any other job activities assigned by the Head of Department (HOD) will also fall under your responsibilities. You will be accountable for regulatory audits, with exposure equivalent to or exceeding USFDA standards. Overall, your role will involve ensuring the quality and compliance of manufacturing and packaging processes through thorough reviews, inspections, and adherence to regulatory standards.,

You will be responsible for the new product development cycle, from product design to delivery to the customer. This will involve conceptualizing the product, creating engineering drawings, defining specifications, designing the processes, packaging, and verifying and validating the product. You will also be required to prepare and share documentation with customers, as well as other external and internal stakeholders. Your role will include continuously working on improving product quality and optimizing processes and materials to ensure competitiveness in the market. You will be responsible for strategizing innovative products while collaborating with cross-functional teams. Additionally, you will be involved in feasibility studies for new projects and product manufacturing, preparing reports on the investment required for product development, costing, and presenting them to management for decision-making. It will be your responsibility to develop new processes, validate them through trials and testing, and commence production while maintaining all related documentation and formalities. You will provide support in analyzing problems in ongoing processes and offering solutions. Basic training to enhance the skills and techniques of other stakeholders for better production and improvement will also be part of your role. Vendor development and sourcing will fall under your responsibilities. You will also be involved in resolving customer complaints in collaboration with other stakeholders. This is a full-time job with benefits such as cell phone reimbursement, performance bonuses, and a day shift schedule. The work location is in person.,

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You will also be responsible for implementing and maintaining a quality risk management system in alignment with regulatory guidelines. Additionally, you will prepare and review Batch Manufacturing Records (BMRs) to ensure accuracy and compliance with regulatory requirements, as well as coordinate and execute process validation activities while ensuring compliance with regulatory standards. Furthermore, you will develop and maintain packaging material specifications, prepare and review Annual Product Quality Reviews (APQRs), coordinate cleaning validation activities, manage deviations from established processes and procedures, oversee change control activities, prepare batch cards, and coordinate technology transfer activities. Collaboration with Regulatory Affairs (RA) and Research & Development (R&D) teams on quality-related matters will be essential to ensure effective communication and coordination on quality-related activities. To be successful in this role, you should possess a Master's degree in Pharmacy along with a minimum of 3-7 years of experience in a QA/QMS role within the pharmaceutical industry. Strong knowledge of regulatory requirements such as cGMP, ICH, and ISO 9001 is necessary, along with excellent analytical, problem-solving, and communication skills. The ability to work independently and lead cross-functional teams will also be vital for this position. As part of our team, you will receive a competitive salary based on your present package and industry norms, along with opportunities for professional growth and development in a collaborative and dynamic work environment. If you are an eligible, motivated, and detail-oriented professional with a passion for quality management, we invite you to submit your application for consideration.,

As a member of the product development team, you will be responsible for conducting literature searches, gaining a deep understanding of the product, and interpreting data for further development. Your role will involve designing primary product strategies and preparing them for discussion with group leaders or team leaders. You will be involved in planning and executing product development work to achieve the desired product profile, as well as compiling relevant data. In this position, you will be responsible for executing and evaluating various formulation optimization trials and process optimization trials, while also compiling the resulting data. Additionally, you will be required to maintain laboratory notebooks, assist in documenting controlled documents, and compile development data for reference. Your role will also include the execution of scale-up activities, exhibit batches, characterization batches, process validation batches, and commercial batches at manufacturing locations. You will be expected to prepare documents that facilitate the smooth execution of scale-up and exhibit batches, including justifications of specifications, Quality by Design (QbD) elements, and Master Formula Card (MFC). This role requires flexibility to work across different markets, including India, the US, OAM, and EM. You will have the opportunity to contribute to the development of innovative products and processes that meet the needs of various markets.,

Job description: About the team: ZF&aposs Commercial Vehicle Solutions (CVS) division helps shaping the future of commercial transportation ecosystems. Our mission is to be the preferred global technology partner for the commercial vehicle industry. What you can look forward to as Assistant Manager/Senior Engineer: Participate in cross functional team to optimize manufacturing process and Process Engg for new product development projects. Lead in developing new machine, processes & installation etc. Know-how of types of sensors, its application and knowledge of pneumatics required. Preparation of process documents PFMEA, PFD, CP & WI, driving process parameter through process validation. Productivity improvement through cycle time reduction, process capability study Cp&Cpk. Should have hands on work experience for machining & welding (MAG) trails. Knowledge about machining programming (CNC, VMC) & welding robot programming. Experience in Digitization of process and Industry 4.0. Implementation of lean manufacturing in shopfloor. Initiating & executing Low-Cost Automation, VAVE projects & Kaizen. Awareness and participation in regional customer new model readiness (APQP) audits. Reduction in internal & customer PPM. Basic awareness of IATF, VDA, OHSAS and ISO 14001 management systems Profile description: Your Profile as Assistant Manager/Senior Engineer: B.E Mechanical in Mechanical /Automobile with 5 7 years of experience or Diploma in Mechanical Engineering with 8-10 yrs in similar function in Automotive industry/Auto ancillaries. Knowledge basic manufacturing process (casting, forging, rubber molding, Coating, Platting, Tube manufacturing, etc.) Participate in cross functional team to optimize manufacturing process and Process Engg for new product development projects. Lead in developing new machine, processes & installation etc. Know-how of types of sensors, its application and knowledge of pneumatics required. Preparation of process documents PFMEA, PFD, CP & WI, driving process parameter through process validation. Productivity improvement through cycle time reduction, process capability study Cp&Cpk Should have hands on work experience for machining & welding (MAG) trails. We offer: Why should you choose ZF Group in India Innovation and Technology Leadership: ZF is at the forefront of technological advancements, offering a dynamic and innovative work environment that encourages creativity and growth Diverse and Inclusive Culture: ZF fosters a diverse and inclusive workplace where all employees are valued and respected, promoting a culture of collaboration and mutual support Career Development: ZF is committed to the professional growth of its employees, offering extensive training programs, career development opportunities, and a clear path for advancement. Global Presence: As a part of a global leader in driveline and chassis technology, ZF provides opportunities to work on international projects and collaborate with teams worldwide. Sustainability Focus: ZF is dedicated to sustainability and environmental responsibility, actively working towards creating eco-friendly solutions and reducing its carbon footprint. Employee Well-being: ZF prioritizes the well-being of its employees, providing comprehensive health and wellness programs, flexible work arrangements, and a supportive work-life balance. Priyanka ZF Group Show more Show less

The Manager Quality Assurance position involves collecting, analyzing, and presenting data related to goods receipt rejection, line rejection, and rework to generate action points for continual PPM reduction. You will be required to prepare CAPA (Corrective and Preventive Action) 8D, Why-Why Analysis, and Cause and Effect Diagrams. Additionally, you will assess the implementation of Quality Plans and Quality Control Plans. Your responsibilities will include reducing in-house rejection/rework and developing action plans if defined goals are not met. Motivating employees to maintain high-quality work and ensuring safety protocols for operators will be crucial. You will also implement corrective and preventive actions for inward quality defects and monitor process rejections. Process improvement activities through Kaizens and Poka-Yoke implementation will be part of your role. You will prepare and display departmental performance indicators such as customer complaints, customer returns, and in-house P.P.M. You will conduct internal Quality System/Process Audits to verify Quality Standard Requirements and implement actions against identified non-conformities. Other tasks include process validation, short-term and long-term countermeasures using 7 Q.C. tools, and analyzing daily/monthly rejection and rework to improve in-house quality. You will be responsible for preparing Quality M.I.S on a monthly basis and reviewing PFMEA with respect to occurrences, customer complaints, and modifications in control plans and drawings. Supplier audits, received Supplier CAPA, and Supplier Audit Plans will be managed by you. Handling customer complaints through brainstorming, Fishbone diagram, and preparing CAR/CAPA will be essential. Collaboration with the development team for new process and product developments is required. Maintaining quality-related documents as per ISO 9001:2015 standards, conducting machine capability/SPC/product audits, and ensuring proper material traceability are part of your duties. You will also oversee vendor performance in terms of quality, including vendor visits. This is a full-time position with benefits such as provided food, health insurance, leave encashment, life insurance, and Provident Fund. The schedule is day shift with a yearly bonus. The work location is in person.,