96 Gdp Jobs - Page 3

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and productivity.

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries in logbooks, worksheets, and other controlled documents. Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents. Coordinate with analysts and the QA team to ensure timely corrections or clarifications. Ensure timely completion and archival of reviewed documents. Provide support during internal and external audits (regulatory and customer). Participate in continuous improvement initiatives within the QC function. Preferred candidate profile Education: B.Sc / M.Sc in Chemistry / Pharmaceutical Sciences or related field. Experience: 4 -8 years of experience in Quality Control, preferably in API manufacturing. At least 2 years in a QC Reviewer role. Technical Skills: Hands-on experience and data interpretation of analytical instruments like HPLC, GC, FTIR, UV, KF, etc. Thorough understanding of cGMP, GLP, and regulatory requirements. Good documentation and analytical skills. Key Competencies: Attention to detail. Strong analytical and problem-solving skills Good communication and interpersonal skills Ability to manage priorities and meet deadlines High integrity and compliance mindset

Experience in pharma regulatory & QMS function, primarily in RLD / comparator sourcing, clinical trial supply chain management, and clinical packaging for USA and EU markets. The role includes supporting the end QMS function and regulatory affairs. Health insurance Provident fund Annual bonus

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

Roles and Responsibilities 1. Responsible for production machinery operation and maintenance activity 2. Checking the day logbooks and maintain all data in control. 3. Train the new operators for the filling machine and sterilizers. 4. co ordinate with supplier for spares development and final design. 5. Responsible for Mould change over in FFS (Form Fill Seal) and ISBM (injection stretch blow Mould) machine as per product size. 6. Responsible for product targets,rejection control and yield maintenance at filling stage for each filling lines. 7. Responsible for production sterilizer maintenance and assist in operational problems. 8. Responsible for maintenance of production vessel and autoclave. 9. Maintain the online training records. 10. Maintain the production filling and sterilizers history and its data. 11. To fill QMS activities like CAPA, Change control and deviation.

Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management:Performqualityoversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus

Position : Assistant Manager- Production Location : Dahej Experience : 4-8 Years CTC Range : 5-9 LPA 1. Production Operations: Check and verify labels of raw materials, packing materials, and solvents before usage. Maintain appropriate storage conditions of raw materials and intermediates in the plant. Ensure adherence to process conditions during batch processing as per BMR (Batch Manufacturing Records). Take instructions from Shift In-charge / Managers for batch charging and monitoring. Report any deviations or discrepancies in plant/process to the Shift In-charge immediately. Complete assigned production tasks within the stipulated time. Maintain environmental conditions in the Production/Intermediate areas as per SOP. Perform reconciliation of accessories used in Production/Intermediate areas. Ensure zero contamination in the finished product. Perform packing and repacking activities as per operational requirements. Follow proper gowning and entry procedures in Production/Intermediate areas. Operate plant equipment and utilities as per operational SOPs. 2. Documentation: Complete online BPRs (Batch Processing Records), equipment usage records, and cleaning records accurately and timely. Maintain area pressure records, centrifuge bag records, and other documentation relevant to the Production area. Update equipment status boards and ensure the online completion of usage logs. Ensure proper labeling of fiber drums, hose pipes, and other batch-related tools. Ensure calibration of equipment such as weighing balances, pH meters, etc., as per SOP. 3. cGMP & Compliance: Guide and train workmen in the Finished Powder Processing section. Ensure the yield and quality of finished products meet predefined standards. Ensure packing of finished products is done as per SOP. Maintain cleanliness of the equipment and assigned production area. Participate in regular trainings to stay updated on cGMP, technical knowledge, and safety standards. Maintain and update personal training records regularly. Ensure reconciliation of intermediate products and cleaning materials. Remain aware of MSDS for all handled materials. 4. Safety, Health & Environment (EHS): Educate and supervise plant operators on safe chemical and equipment handling to prevent accidents. Coordinate with the EHS department for safety permits and compliance. Use scrubbers where required to prevent air pollution. Ensure no spillage of solvents and minimize material wastage. Shut off utility supply valves when not in use. 5. Interdepartmental Coordination: Coordinate with QC department for timely receipt of analysis reports. Coordinate with Engineering Services for any maintenance work required during the shift. Interested Candidate Please share your CV on Gmail- meet.chauchan@cadilapharma.com and also fill the detailes in the given link below: https://docs.google.com/forms/d/e/1FAIpQLScIYJJHOYg-KHEYPPmJXeN7e22-6-4spVE1BbsCG9E_XftzMQ/viewform?usp=header

The ideal candidate must have prior experience in pharma warehouse management, with a strong understanding of compliance, inventory control, and efficient warehouse practices at our ALC Baruipur facility.

Roles and Responsibilities Manage inventory control processes, including GRN, GDP, and stores management. Ensure accurate stock records through regular audits and reporting. Coordinate with suppliers for timely delivery of materials and equipment. Conduct physical counts to verify inventory accuracy and identify discrepancies. Implement quality control measures to maintain high standards in store operations.

Harman Finochem is looking for a skilled Technology Transfer Executive to join our team. In this role, you'll be crucial in facilitating seamless technology transfers, ensuring robust documentation, and maintaining compliance with key regulatory guidelines. If you have hands-on experience with process validation, cGMP, and possess strong analytical and communication skills, we encourage you to apply! Key Responsibilities Documentation & Compliance: Prepare and manage essential documents such as BMR (Batch Manufacturing Record), Process Validation Reports, Stability Protocols, and Sampling Plans . Initiate and ensure the proper closure of Change Controls and Deviations in accordance with GMP (Good Manufacturing Practices) . Apply good knowledge of GDP (Good Documentation Practices) . Maintain good knowledge of regulatory guidelines including SUPAC (Scale-Up and Post Approval Changes), cGMP, Compliance, ICH Q1A, Q2, Q7, Q8, Q9, A10, and Q13 . Gap Assessment: Conduct GAP assessments between sending and receiving unit equipment, instruments, and documents to identify and address discrepancies. Scale-Up/Down & Experimentation: Utilize sound Scale-up/down knowledge , including calculations, forecasting, and risk assessment. Plan and perform Lab-scale experiments . Communication & Coordination: Ensure effective communication and coordination with Cross-Functional Teams (CFTs). Software Proficiency: Demonstrate hands-on experience with Advanced Microsoft Word, PowerPoint, and Excel . Preferred Candidate Profile Experience: Must have experience in Tech Transfer Department Documentation . Education: M. Pharma in Pharmaceutics. Software Proficiency: Proficiency in MS-Word, Excel, and PowerPoint. Perks and Benefits As per Company Standards.

The Life Sciences Senior system engineer is an integral member of the Life Sciences Hub team, who reports to LE/PE and undertakes the Design, Implementation, Internal testing and Factory acceptance test of respective Process/Function area for Process Systems and Solutions (PSS) projects. The senior system engineer in Life Sciences Hub: Supports Lead engineer as Area/Sub lead for the Medium to Large size projects. Has good knowledge of the DeltaV system and exposure to S88 architecture . Has hands on experience on Batch process Applications e.g- in Biotech, Pharma, F&B, Terminal automation etc. Has Design and configuration experience of Medium to Complex Equiment modules/sequences . Understands and has aptitude to follow strict procedural guide lines and adherence to standards . Has penchant for details and documentation . Reviews and guides System engineerss work. Independently lead small size projects. Coordination with overseas offices and customers To understand and document the Scope, Schedule and Budget of work to be done. Channelling the TQ’s. Weekly meetings. Progress reporting. Project Execution – Interpret PFD and other project documentation to develop Process Functional requirement. Interpret Functional requirement documents and developing Detail Designs Documents Develop Configuration and Test guidelines. Develop Test Specifications and supervise/execute Test protocols Design, implementation and testing of User interface system including Dynamo/FP/DT/Batch. Conducting or participation in FAT/SAT/Commissioning. Have strict Vigil on Scope creeps and Scope changes Escalate project issues/risk proactively to lead engineer/PM, if possible with mitigation plan. Take full ownership of the allocated work and direct sub-ordinates. Coach and develop system engineer skills. Willingness to travel to Customer site or Emerson overseas offices for short/long term Quality Control & Assurance Implementation of EEEC IMS processes/documentation as & when required throughout the project. Adopts to WA quality requirements and Cutomer’s regulatory guidelines Already Certified or gets certified on GAMP5 and GDP requirement of Pharma projects Practices and promotes First time right approach Strictly follows GDP (Good Documenattion Practices) Other Duties – Perform other additional specific duties, when requested by the business. These will, typically, be strategic in nature but could potentially be anything that the post holder is suitably qualified and experienced to undertake. These duties may be assigned to the person under guidance of a supervisor. TECHNICAL SKILLS: DCS – Software, (Batch and S88 Applications desirable) Third party interfaces (Modbus, Profibus, OPC etc.) Validation aspects (desirable). PCSD Library. PMO project execution processes and Tools MS-Office, Visio SOFT SKILLS (Korn Ferry): Communication : Ability to understand the customer requirement and translate it into quality deliverables, to converse and get ideas across the team and to communicate with peers/junior resources with a view of eliminating work related/project related issues. Has good oral and written skills, follows email etiquetts. Able to conclude or have clear understanding after any discussion. Decision Making : Ability for taking appropriate decisions that would result in meeting the deliverables to the satisfaction of the customer. Planning & Organising : Ability for planning and scheduling activities/priorities for ensuring on time deliverables. Helping junior resources in planning and scheduling their work. Initiative : Helps team deliver high on performance as a whole, pro-activeness shown in in accepting responsibility for new development.Working out alternatives/solutions to issues without being told by the supervisor within minimum acceptable time. Guiding Junior resources for resolution of issues without being told by the supervisor. Ability to study and adapt to new technologies. Productivity : Able to find optimum way to do the job in less than budgeted hours without any defect consistently on different tasks/ activities/ projects Quality : Able to implement defect-free configuration within budget. Guidance given to peers, junior resources for creating error free deliverable. Ownership : Ability to meet project commitments and proactive approach. Team Work : Maintaining the team motivation. Relationship with the peers & subordinates. Creates a climate in which people want to do their best, invites input from each person, makes each individual feel his/her work is important. Dependability & Integrity : Ability to make a commitment regarding resolution of issues, meeting the said commitment and providing timely updates to supervisor.Providing optimum solutions to peers, junior resources with a view of ensuring timely deliverables. Value Creation : Suggest ideas/methods that would reduce time and reduce defects. Out of box thinking .

The Life Sciences Senior system engineer is an integral member of the Life Sciences Hub team, who reports to LE/PE and undertakes the Design, Implementation, Internal testing and Factory acceptance test of respective Process/Function area for Process Systems and Solutions (PSS) projects. The senior system engineer in Life Sciences Hub: Supports Lead engineer as Area/Sub lead for the Medium to Large size projects. Has good knowledge of the DeltaV system and exposure to S88 architecture . Has hands on experience on Batch process Applications e.g- in Biotech, Pharma, F&B, Terminal automation etc. Has Design and configuration experience of Medium to Complex Equiment modules/sequences . Understands and has aptitude to follow strict procedural guide lines and adherence to standards . Has penchant for details and documentation . Reviews and guides System engineerss work. Independently lead small size projects. Coordination with overseas offices and customers To understand and document the Scope, Schedule and Budget of work to be done. Channelling the TQs. Weekly meetings. Progress reporting. Project Execution Interpret PFD and other project documentation to develop Process Functional requirement. Interpret Functional requirement documents and developing Detail Designs Documents Develop Configuration and Test guidelines. Develop Test Specifications and supervise/execute Test protocols Design, implementation and testing of User interface system including Dynamo/FP/DT/Batch. Conducting or participation in FAT/SAT/Commissioning. Have strict Vigil on Scope creeps and Scope changes Escalate project issues/risk proactively to lead engineer/PM, if possible with mitigation plan. Take full ownership of the allocated work and direct sub-ordinates. Coach and develop system engineer skills. Willingness to travel to Customer site or Emerson overseas offices for short/long term Quality Control & Assurance Implementation of EEEC IMS processes/documentation as & when required throughout the project. Adopts to WA quality requirements and Cutomers regulatory guidelines Already Certified or gets certified on GAMP5 and GDP requirement of Pharma projects Practices and promotes First time right approach Strictly follows GDP (Good Documenattion Practices) Other Duties – Perform other additional specific duties, when requested by the business. These will, typically, be strategic in nature but could potentially be anything that the post holder is suitably qualified and experienced to undertake. These duties may be assigned to the person under guidance of a supervisor. TECHNICAL SKILLS: DCS – Software, (Batch and S88 Applications desirable) Third party interfaces (Modbus, Profibus, OPC etc.) Validation aspects (desirable). PCSD Library. PMO project execution processes and Tools MS-Office, Visio Confirmation Questions: 1. This is a permanent employment opportunity with Pyramid IT. Are you fine with this? (Y/N) 3. This position may require working in shifts. Are you fine with this? (Y/N) 4. Current CTC: 5. Expected CTC: 6. Total Experience | Relevant Experience: 7. Official Notice Period: 8. If selected, how soon can you join (in days)? 9. Do you have a Notice Period Buyout option? (Y/N) 10. Preferred day & time for a telephonic/F2F interview on weekdays: 11. Are you currently holding any other offer? (Y/N) 12. Reason for job change: 13. PAN Card Number: 14. Aadhar Number: 15. Alternate Contact Number: Your prompt response along with your updated profile will be highly appreciated. Looking forward to your confirmation.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelors degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance.

Bachelor's degree with over 10 years of experience in designing and developing solutions in Trackwise. Experience working in a GMP environment, 7+ years in an IT Systems Role. Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management. SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP) Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements. Comprehensive understanding of Quality Management processes, regulatory compliance, and industry standards. Certification in Trackwise or Equivalent Experience is required. Strong leadership skills with the ability to manage and mentor a team of analysts and developers. In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA/Deviation, Lab Exception, Audit, Product Complaints, and Supplier Management Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems. Exceptional oral and written communication skills, with the ability to conduct effective presentations, facilitate workshops, and negotiate with stakeholders. Excellent organizational and prioritization skills, capable of managing multiple projects and tasks in a dynamic environment. Proven ability to handle multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support. Experience in all phases of the project life cycle from analysis and design to implementation and testing, with a focus on business process improvement and optimization. Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions. Strong team player with excellent collaboration skills, fostering a positive team environment. Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Job Title: Officer/Senior Officer Location: Ankleshwar Experience: 2-5 Year Department: Production Role and Responsibilities: Production Operations Check labels and verify identity of raw materials, packing materials, and solvents before use. Maintain appropriate storage conditions for raw materials and intermediates in the plant. Execute batch processes as per approved Batch Production Records (BPRs). Follow instructions from Shift In-charge or Production Manager for batch charging and monitoring. Monitor and maintain process parameters during manufacturing. Complete allocated tasks within the stipulated timeline with accuracy. Ensure contamination-free production and proper packing/repacking of materials. Adhere to proper gowning, hygiene, and entry protocols for classified production areas. Operate plant equipment and utilities safely and efficiently. Maintain cleanliness and proper segregation in the production area as per SOP. Documentation & SAP & GDP Perform online documentation of BPRs, cleaning logs, and equipment usage records during the shift. Maintain differential pressure, centrifuge bag records, and other PP/Intermediate area logs. Update SAP transactions for material consumption, yield recording, and inventory movements. Ensure timely entries in equipment logbooks and SAP-based process entries . Label all process equipment, HDPE/fiber drums, and accessories correctly per batch and SOP requirements. Ensure Good Documentation Practices (GDP) by making real-time, legible, complete, and traceable entries in all logs and records. GMP & Compliance Guide and train workmen on cGMP practices and technical SOPs. Ensure finished product yield and quality meet predefined specifications. Participate in internal audits, regulatory inspections, and SOP reviews. Perform calibration of instruments such as weighing balances and pH meters. Keep equipment status boards updated and follow QMS standards. Safety & Environmental Compliance Understand MSDS of all materials handled and ensure safe handling practices. Supervise plant operators to ensure chemical and equipment handling safety. Use scrubbers and proper exhaust systems to control emissions and avoid air pollution. Coordinate with the EHS department for required safety permits and compliance. Wastage Reduction Prevent solvent/material spillage and reduce wastage through proper process control. Ensure utilities (valves, pumps) are turned off when not in use to conserve resources. Cross-Functional Coordination Coordinate with QC for sample analysis and batch release. Liaise with engineering for breakdown and preventive maintenance activities during shift. Work closely with Warehouse, QA, and EHS departments for smooth operations. Interested candidate can share there cv at meet.chauhan@cadilapharma.com .

For Production Incharge : @ Post Graduate Profile only considered (MSC Chem) @ Shift handling @Shift planning @Documents review during shift. Production Operator/ Chemist. @Should follow Gmp @ Should follow documents.

Role & responsibilities To manage and oversee all store operations in a pharmaceutical manufacturing environment while ensuring efficient inventory control, proper documentation, and seamless material flow using SAP. 1. Inventory & Material Management: Oversee receipt, storage, issuance, and dispatch of raw materials, packing materials, consumables, and engineering spares. Maintain accurate inventory records and ensure optimal stock levels to avoid shortages or overstocking. Conduct regular cycle counts and physical stock verifications. 2. Regulatory Compliance & Documentation: Ensure strict adherence to GMP, GDP, and SOPs related to material handling and documentation. Maintain proper documentation for all material movements (e.g., GRNs, issue slips, return notes) as per regulatory standards. Handle audits from regulatory authorities and ensure compliance. 3. SAP System Management: Manage all store transactions in SAP (MM module), including goods receipt, goods issue, stock transfer, and inventory adjustments. Generate MIS reports for stock analysis, expiry tracking, and consumption trends using SAP. Coordinate with IT and SAP support teams for system improvements and troubleshooting. 4. Team Leadership & Coordination: Lead and mentor a team of store personnel, including allocation of duties, performance management, and training. Coordinate with Quality Control, Quality Assurance, Production, Purchase, and Planning departments for seamless material flow. Drive continuous improvement in store processes and layouts to enhance efficiency. 5. Safety & Housekeeping: Ensure proper storage conditions as per pharmacopeial and regulatory requirements (temperature, humidity, segregation). Implement and enforce safety measures for handling and storing hazardous materials. Maintain high standards of cleanliness and organization in the storage areas. *In addition to the above you may be given additional responsibilities as per business requirement and your JD can be altered at the discretion of your superiors. Years of Experience 18 25 years of experience, Proven track record of SAP-based inventory management and documentation. Strong knowledge of pharmaceutical GMP, GDP, and warehousing best practices. Familiarity with documentation requirements for regulated markets. Qualification Graduate in Science/Pharmacy/Commerce (B.Sc./B.Pharm/B. Com) Additional certifications in materials management or SAP (preferred)

*Must be aware of the working conditions in an API/Intermediate unit *Monitoring production planning to meet production target & ensure that the production records are maintained at the time of performance *Knowledge of GMP & GDP procedure to follow Required Candidate profile * Able to handle glass assembly 20L, 50L, 100L, 200L, 300L & Centrifuge 24’’ & 36’’ * Having exposure of handling CF, multi mill, Nutseh Filter, Blender, Shifter * Equipment handling

Key Roles/Responsibilities: Method Development of different drug product Routine analysis of development samples and lab stability samples GMP batch analysis, Stability batch analysis and reporting Peer review for the routine experiment PDLIMS data entry Analysis of raw material and packaging material Validation of analytical methods Calibration and maintenance of analytical instruments Preparation of tentative test procedures for routine development analysis, method development, method validation report and standard test procedure Follow GxP (GMP, GDP etc) for all processes Following in-house compliance system Maintain hygienic condition in respective department. Ensure use of Personal Protective Equipment & attend EHS training & send waste to concerned person & comply EHS requirements Refrigerator temperature monitoring and maintenance. Ensure data integrity Qualifications M.Sc. (Analytical Chemistry)/ M.Pharm (Quality Assurance/Pharmaceutical Analysis)