361 Process Validation Jobs - Page 3

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.,

The ideal candidate for this position will join our R&D/F&D team focusing on Oral Solid Dosage (OSD) forms, including pellets and tablets. You will be responsible for conducting pre-formulation and formulation development studies, process validation, stability studies, and technology transfer of new pharmaceutical products while ensuring adherence to ICH guidelines and internal SOPs. Your key responsibilities will include conducting detailed literature reviews to support new product development initiatives. You will evaluate reference products, patents, regulatory status, and formulation strategies. Additionally, you will perform physicochemical characterization of API and excipients, assess compatibility, solubility, and stability as part of pre-formulation studies. In the formulation development phase, you will design and develop robust formulations for tablets and pellets. You will optimize process parameters through laboratory and pilot-scale trials. Stability studies will be conducted following ICH guidelines and internal SOPs, where you will interpret results and recommend necessary formulation or process adjustments. You will coordinate and execute process validation batches in the production department, ensuring compliance with GMP and validation protocols. Technology transfer responsibilities will include preparing and reviewing complete technology transfer documentation (TTD) and facilitating successful scale-up and handover of developed products to manufacturing. In case of troubleshooting, you will provide technical support for commercialized products to resolve formulation or process issues. Documentation and record-keeping tasks will involve preparing and updating Product Development Files (PDF), Product Logbooks, and Instrument Logbooks regularly. Additionally, you will draft and review documents such as QAQN (Quality Assessment & Qualification Note), MFR (Master Formula Record), and FPS (Finished Product Specification). Qualifications required for this position include a B.Pharm/M.Pharm in Pharmaceutics or Pharmaceutical Technology and 13 years of relevant experience in F&D/R&D, preferably in OSD (tablets/pellets) formulation development in a regulated environment.,

The Senior QA Executive plays a crucial role in overseeing various aspects of quality management within the organization. This includes but is not limited to document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management. The position also involves contributing to change control, supplier evaluation, risk management, product and process validation, complaint handling, CAPA support, and quality improvement projects. A key part of the role is to engage in data entry, analysis, and report preparation to ensure alignment with quality and compliance objectives. Responsibilities of the role include: - Document Control: Assisting in the organization and maintenance of quality documentation such as the Quality Manual, Documented Procedures, Standard Operating Procedures (SOPs), and forms. - Internal Audits: Participating in internal audits across various departments to evaluate compliance with the Quality Management System (QMS) and providing reports to senior QA staff. - Non-Conformance Management: Supporting the investigation of non-conformities or deviations, including root cause analysis and the development of corrective and preventive actions (CAPAs). - Change Control Support: Aiding in the change control process by reviewing change requests and assessing their impact on quality and compliance. - Risk Management Assistance: Collaborating with senior QA staff to conduct risk assessments and implement risk management strategies. - Product and Process Validation Support: Participating in activities related to product and process validation to ensure they meet specified requirements. - Complaint Handling Support: Assisting in the review and resolution of customer complaints pertaining to product quality. - Corrective and Preventive Action (CAPA) Support: Supporting CAPA processes by collecting data and monitoring the progress of corrective actions. Candidates for this role are expected to have a Bachelor's or Master's degree in a life science background and ideally possess 2 to 4 years of relevant experience in a similar role within the IVD industry. Interested candidates are encouraged to share their CVs with hr2@athenesedx.com to be considered for this position.,

We are looking for a candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise. Roles & Responsibilities You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing. You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc. You will be responsible for process validation for Sterilization, Washing, Aseptic filling, and cleaning procedures. You will evaluate change controls, deviation, and incident, (OOS) out of specification, (OOT) out of trend, and risk management. You will prepare the production process SOPs (Standard Operating Procedures) and batch records. You will provide training on GMP (good manufacturing practices). You will apply knowledge of aseptic processes, Lean, OEE (Overall Equipment Effectiveness), and similar KPIs (Key Performance Indicators). You will respond to queries and questions regarding regulatory audits such as US FDA (Food and Drug Administration). Qualifications Educational Qualification A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a related field Minimum Work Experience 7 years of experience in pharmaceutical manufacturing operations Skills & Attributes Technical Skills Expertise in line operations, especially in manufacturing activities like CIP, SIP, and batch manufacturing. Proficiency in understanding equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC, water system, compressed air, Nitrogen system, etc. Understanding of Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures. Knowledge for evaluation of change control, deviation, incident, out of specification, out of trend, and risk management. Experience in preparing production process SOPs and batch records. Understanding and application of Aseptic processes, Lean, OEE, and similar KPIs. Hands-on experience in regulatory audits, particularly with agencies like the US FDA. Good understanding of GMP and good laboratories practice. Behavioral Skills Capacity to provide training on GMP and other relevant areas. Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment. Efficiently manages time to meet production schedules and deadlines without compromising quality. Must have hands-on experience in sophisticated manufacturing machines and equipment. Effective communication and training skills for user departments and service providers.

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations. Roles & Responsibilities Responsible for Validation which shall include:Preparation/Review/Approve of MPR.Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report. Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities.Execution of Tech transfer products at Receiving Units. Responsible for QIP which shall include: Identifying root cause for QIP.Execution of QIP. Conclusion/Recommendation of QIP. Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT. Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements. Follow up & coordinate with cross functional team for execution of validation. Give the input for the monthly reporting system, participate in the internal & external audits, present the documents to auditor's/inspection team. Qualifications Educational qualification: Masters/Bachelors/Ph.D in pharma Minimum work experience: 6 -8 years of experience in Process development / MSAT / Tech transfer Skills & attributes: Technical Skills Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (OSD) Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches. Knowledge of International Council for Harmonization (ICH) guidelines related to Product development or Process Development.

Dr Reddys is seeking Manufacturing specialist specializing in cell therapy (CAR-T) programs. This position is part of our Manufacturing facility. The manufacturing role serves as a Specialistin CAR-T production facility. You will work closely with our Research and Product Development teams to support the GMP Manufacturing operations, Technology transfer, quality assessments, and supply chain logistics and process validation of the CAR-T process across a wide range of novel modalities for Cell therapy programs. Role Responsibilities: As a Manufacturing specialist, a typical day might include the following: Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development/commercialization. Lead and train a team of cell process scientists/engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals. Manage and/or execute T-cell culture and differentiation to support process development, characterization, and validation. Manage troubleshooting with a high degree of complexity. Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter/result ranges. Support the development of SOPs and batch records, risk assessments as well as the technology transfers. Review completed production batch records and assist with deviations, CAPAs, Change Controls, and investigations. Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions. Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and support/lead projects with a fully integrated team to facilitate successful outcomes. Serve as an internal technical subject matter expert and support technology transfers, engineering, and PV batches. Coordinate resources and set priorities for own/team, contributing to the overall goals of the department. Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable. Align with leadership to develop strategic roadmap on continuous medium optimization and phase-appropriate medium development and implementation. Manage the medium development team to ensure timely delivery of cell culture medium development and optimization projects. Empower and support junior team members to independently plan and design experiments. Continuously grow and encourage team members on scientific and critical thinking. Qualifications PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology or a relevant life-science discipline, with relevant 915 years of industry experience within Cell and gene therapy, biologics manufacturing/product development functions.

The job involves conducting literature search, enhancing product understanding, and interpreting data for product development. You will design primary product strategies and prepare them for discussion with group leaders or team leaders. It is important to plan and execute product development work effectively to achieve the desired product profile and compile relevant data. You will be responsible for scheduling work plans in consultation with group leaders or reporting authorities to ensure timely project completion based on assigned priorities. Additionally, the role includes executing and evaluating various formulation optimization trials, process optimization trials, and compiling data. You will be required to write in the laboratory notebook and assist in documenting controlled documents while compiling development data. Furthermore, the job entails executing scale-up, exhibit batches, characterization batches, process validation batches, and commercial batches at manufacturing locations. Moreover, you will prepare documents to facilitate the smooth execution of scale-up and exhibit batches, such as Justification of specification, QbD elements, MFC, etc.,

The position is based out of Chennai and does not offer a remote work option. The salary offered is between 5-8 lacs CTC based on validation experience. At Quascenta, we specialize in providing comprehensive validation lifecycle management software solutions. Our mission is to empower pharmaceutical manufacturing sites by offering software tools to streamline product manufacturing and cleaning processes, ensuring compliance, efficiency, and savings. Our flagship products, such as eResiduePro, eProcessPro, and eLogBook, aim to transform how companies manage their product, process, and cleaning lifecycles. With over 20 years of experience, our solutions help organizations meet regulatory requirements while enhancing operations. This full-time on-site role is for a Pharmaceutical Validation Subject Matter Expert (SME) based in Chennai. The selected candidate will offer technical support on software products like ValDoc Pro, eLog Pro, and QMS Pro to client companies. Responsibilities include assisting customers with uploading SOPs, managing qualifications in the application, executing qualification scripts (IQ/OQ/PQ) online, writing and executing test scripts, and opening bug tickets when necessary. Qualifications for the role include prior experience with QMS software, equipment/instrument qualification, and process validation. Fluency in Hindi is a mandatory requirement.,

As a maintenance engineer, your primary responsibilities will include maintaining facility and equipment, procuring engineering consumables and proprietary spares, and managing inventory. You will be responsible for performing and approving qualification studies for equipment and facilities, as well as scheduling and executing preventive maintenance programs for plant and utility equipment. Additionally, you will review and participate in process validation programs, update technical drawings such as plant layout and P & ID, and manage annual maintenance programs for utility and material handling equipment. You will also be involved in arranging instruments for plant equipment, ensuring compliance with quality documents, and meeting statutory requirements related to boiler/electrical inspections and standard weights. Your role will also involve executing plant modifications as per approved capex and plant requirements, maintaining cGMP and EHS compliance, and organizing training for department employees on SOPs, new systems, and qualifications. You will review maintenance reports and energy consumption data to identify areas for improvement and take corrective actions as necessary, in addition to overseeing the annual engineering budget. Overall, you will play a crucial role in ensuring the smooth operation and maintenance of plant equipment and facilities, while upholding high standards of quality, compliance, and safety.,

As a dedicated Downstream Process Engineer, you will be responsible for analyzing the current downstream processes to identify bottlenecks and inefficiencies. Your expertise will be crucial in implementing effective strategies to enhance process yield, purity, and throughput. Leading a team of engineers and technicians, you will provide technical guidance and support to ensure optimal performance and foster a culture of innovation, collaboration, and continuous improvement. Your commitment to excellence includes ensuring compliance with all regulatory standards and quality control procedures. By implementing robust quality control measures, promptly investigating and resolving quality issues, and developing and executing process validation protocols, you will uphold the highest product quality standards. You will also analyze validation data to ensure adherence to regulatory requirements. In your role, you will oversee the operation and process control of various equipment such as centrifuges, lyophilizers, laminar air flow systems, clean rooms, blast storage (cold rooms), CIP systems, and reactors. Monitoring OEE (overall equipment efficiencies) and ensuring the calibration of downstream processing equipment are essential tasks. Additionally, you will plan and schedule equipment maintenance to minimize downtime and optimize resource utilization while controlling operational costs. Your proactive approach will involve identifying opportunities for cost reduction without compromising quality standards. Staying informed about relevant regulatory guidelines and industry standards is imperative to ensure compliance with GMP and GLP requirements. Maintaining accurate and up-to-date process documentation, preparing technical reports, and delivering presentations will be part of your routine tasks. If you are a detail-oriented professional with a passion for optimizing downstream processes and ensuring product quality, we invite you to join our dynamic team and make a significant impact on our operations.,

A QA Manager in the pharmaceutical industry is responsible for developing, implementing, and maintaining quality assurance systems and processes that ensure products meet regulatory standards and customer expectations. he

Ensure current versions of all GMP documents are in use. Prepare, revise, and control SOPs . Implement and enforce (GDP). Conduct internal audits, maintain summaries and CAPA tracking Support in process validation, equipment qualification etc Required Candidate profile Ensure all QA activities comply with cGMP, regulatory requirements & internal quality standards for API & Specialty manufacturing. Contact Mr Deep at 9867038868, Email Id: ops@empowerrecruitments.com

Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement. To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents. Preparation & review of Annual Product Quality Review. Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports Work Experience 7-9 year Education Masters in Science or Pharmaceutical Chemistry Post Graduation in Pharmacy Competencies

Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com

Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

You will be responsible for conducting literature searches, gaining a thorough understanding of the product, and interpreting data for product development purposes. Additionally, you will design primary product strategies and prepare product strategies for discussion with group leaders or team leaders. Your role will involve planning and executing product development work to achieve the desired product profile, as well as compiling data. You will be required to schedule work plans in consultation with group leaders or reporting authorities to ensure timely project completion based on assigned priorities. Furthermore, you will carry out the execution and evaluation of various formulation optimization trials, process optimization trials, and data compilation. It will also be your responsibility to write laboratory notebooks and assist in documenting controlled documents, as well as compiling development data. You will be involved in the execution of scale-up, exhibit batches, characterization batches, process validation batches, and commercial batches at manufacturing locations. Additionally, you will prepare documents to ensure the smooth execution of scale-up and exhibit batches, including Justification of specification, QbD elements, MFC, etc.,

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,

As an Executive in MSTG at Sun Pharmaceutical Industries Ltd, your primary responsibility involves executing technology transfers to Sun/CMO sites, overseeing scale-up processes, exhibit batches planning, and process validation. This requires effective planning and efficient utilization of resources such as manpower, materials, and machinery. You will be responsible for various documentation tasks including the preparation of new production introduction forms, scale-up reports, reviewing Sun/CMO Batch Manufacturing Records (BMR), developing sampling plans, process validation (PV) protocols, User Requirement Specification (URS) preparation, and Dashboard preparation. It is essential to ensure that products are manufactured and stored in compliance with relevant documentation to achieve the desired quality standards. Additionally, your role includes reviewing and providing comments on Master Formulae (MF), Failure Mode and Effects Analysis (FMEA), Risk Assessments (RA), and protocols such as Sampling plans and Process Validation protocols to ensure regulatory compliance. You will also be involved in handling and supporting troubleshooting batches for data comparison and root cause investigation at Sun/CMO sites, investigating product troubleshooting, and overseeing timely packing operations. Furthermore, you are required to monitor and conduct pre-checks on equipment planned for use in scale-up, exhibit, and process validation batches, including equipment preparation, vial washing and dehydrogenation, Clean-in-Place/Sterilize-in-Place (CIP/SIP) systems, Programmable Logic Controllers (PLCs), and various instruments. Your role also involves supervising and conducting skid trials to enhance product development, improve processes, and address potential manufacturing constraints effectively.,

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc Must be flexible to work across any market: India, US, OAM, and EM.

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc Must be flexible to work across any market: India, US, OAM, and EM.

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certificates, issuance and archival of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), preparation of Annual Product Quality Review (APQR), line clearance for manufacturing, packing, and dispensing activities, sampling of bulk and finished goods, and review of production records. Furthermore, you will play a key role in managing change controls, deviations, and CAPA (Corrective and Preventive Actions), conducting complaint handling, updating departmental SOPs, providing training as per schedule, coordinating training programs with HR, and ensuring documentation management as per SOP. You will also be responsible for providing necessary documents/data to meet internal and external quality, environmental, health, and safety requirements. Moreover, you will be involved in compliance monitoring through self-inspection programs, audit compliance coordination, preparation of responses to audit reports, and execution of food/dietary supplements regulations for export markets. You will also oversee the implementation of sanitation programs, adherence to EHS norms, and various corporate initiatives. Piramal Group values equal employment opportunity, ensuring that all applicants and employees are treated fairly based on merit, qualifications, skills, and performance. As part of a globally integrated network of facilities, Piramal Pharma Solutions offers a wide range of services across the drug life cycle, making it a trusted partner for innovators and generic companies worldwide.,

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

As an NPD Manager, you will be responsible for leading the end-to-end new product development process, ensuring compliance with industry standards, and driving innovation by identifying new technologies and materials. You will develop and manage project timelines, budgets, and resource planning for NPD initiatives, while coordinating with cross-functional teams to monitor project progress and address risks for timely product launch. Your role will involve working closely with customers and suppliers to understand requirements, conducting market research to identify industry trends, and providing technical support during customer discussions and presentations. You will implement best practices in NPD processes and ensure all product designs meet quality, safety, and performance standards through design reviews and risk assessments. To qualify for this position, you should have a Bachelor's or Masters degree in Mechanical Engineering, Automotive Engineering, or a related field, along with at least 5 years of experience in new product development, preferably in the automotive sector. Strong knowledge of APQP, PPAP, DFMEA, PFMEA, GD&T, and CAD tools is required, as well as excellent project management, problem-solving, communication, and leadership skills. If you are passionate about driving innovation, managing projects effectively, and ensuring the successful launch of new products, we encourage you to apply for this full-time position located in Partapur (Meerut) with a salary of up to 45k. Don't miss this opportunity to join our manufacturing company and contribute to our success in the industry. Please send your resume to 8439277155 or 8279756611, or email it to hr@careerplus-jobs.com. We offer benefits such as cell phone reimbursement, health insurance, and Provident Fund, along with a yearly bonus. The work schedule is day shift, and proficiency in English is preferred for this role. Join us in person at our work location and be a part of our dynamic team dedicated to new product development and excellence in the automotive sector.,