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5.0 - 9.0 years
2 - 6 Lacs
baddi
Work from Office
1. To prepare annual equipment qualification planner with respect to validationmaster plan. 2. To prepare HVAC / compressed air / effectiveness of cleaning validation planner. 3. Preparation of protocols for qualifications of newly procured equipments and ofequipments transferred from other location. 4. Preparation of protocols for re-qualifications of HVAC system. 5. Preparation and execution of re-qualification protocols and reports as per schedule ofvalidation master plan and as on when required. 6. Toperform cleaning validation cleaning verification. 7. Preparationreview of cleaning assessment report. 8. Preparation review of process validation protocols and reports. 9. Preparation revie...
Posted 3 days ago
2.0 - 5.0 years
1 - 4 Lacs
baddi
Work from Office
Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.
Posted 3 days ago
2.0 - 5.0 years
1 - 4 Lacs
baddi
Work from Office
1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...
Posted 3 days ago
1.0 - 5.0 years
1 - 2 Lacs
hyderabad
Work from Office
Manage day-to-day office operations, including administrative tasks and employee coordination. Handle communications, both internal and external, ensuring timely responses and follow-ups. Organize meetings, prepare agendas, and take minutes for effective documentation. Maintain office supplies and ensure all equipment is in working order. Assist with budgeting, invoicing, and other financial tasks as needed.
Posted 3 days ago
1.0 - 13.0 years
4 - 5 Lacs
jamnagar
Work from Office
Supervise jetty crew for safe mooring and unmooring operation at jetty berths Coordinate with pilot and align vessel with load arm during berthing Connect, disconnect and drain load arm before and after cargo operations Carry out ship shore safety check list and periodic checks during cargo operation Test jetty equipment periodically and maintain records Issue work permit and ensure compliance to permit conditions Raise SAP notification for defects of jetty equipment Impart tool box talks to jetty crew and contractor personnel Carry out bunker check of crafts Ensure good housekeeping at berths Jetty Officer Education Requirement : Diploma in Mechanical engineering or equivalent degree awarde...
Posted 3 days ago
2.0 - 7.0 years
4 - 6 Lacs
navi mumbai
Work from Office
experience in Vaccine or Biosimilar manufacturing Strong exposure to In-Process Quality Assurance & Quality Management Systems and review system Knowledge of GMP guidelines and documentation practices fast-paced, regulated environment Perks and benefits 5- days working, Pf , health insurance
Posted 3 days ago
5.0 - 10.0 years
3 - 7 Lacs
hyderabad
Work from Office
Overview We are seeking a highly organized, proactive, and detail-oriented Executive Assistant to support our Senior Vice President (SVP)/ Vice President (VP). This role requires a high level of professionalism, discretion, and the ability to anticipate needs while managing a wide range of administrative and executive support tasks in a fast-paced environment. Responsibilities Manage and optimize the SVP/VPs calendar, scheduling meetings, appointments, and travel arrangements. Prepare, review, and organize correspondence and other confidential documents. Coordinate internal and external meetings, including logistics, agendas, and follow-ups. Serve as a liaison between the SVP and internal/ex...
Posted 3 days ago
4.0 - 5.0 years
2 - 4 Lacs
ankleshwar
Work from Office
Responsibilities: Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support. Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+). QMS Ownership: Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment. Documentation Control: SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP. Vendor & Material Quality: Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability. Tr...
Posted 3 days ago
1.0 - 3.0 years
2 - 3 Lacs
vapi
Work from Office
Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines, FDA documentation requirements, and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the Quality Control Laboratory to ensure all testing is performed ...
Posted 3 days ago
2.0 - 7.0 years
4 - 8 Lacs
gangtok
Work from Office
Job Title: Officer -QA Business Unit: Global Quality And Compliance Job Grade G12C Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: To give the line clearance as per BMR/BPR...
Posted 3 days ago
7.0 - 12.0 years
5 - 10 Lacs
satara
Work from Office
Role & responsibilities To ensure cGMP Compliance as per laid down procedures. Monitoring overall all QA activities - Process validation, Cleaning Validation, Equipment Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other ...
Posted 3 days ago
0.0 - 3.0 years
2 - 3 Lacs
ankleshwar
Work from Office
Role & responsibilities: We are looking for a dedicated and detail-oriented Officer QA to join our team. The ideal candidate should have hands-on experience in IPQA, Sampling, or BMR review. Perform In-Process Quality Assurance (IPQA) activities. Responsible for line clearance, process monitoring, and ensuring compliance with cGMP practices. Conduct sampling of raw materials, intermediates, and finished products as per defined procedures. Prepare, review, and maintain Batch Manufacturing Records (BMR) and related QA documentation. Preferred candidate profile B.Sc / M.Sc with 1 to 3 years of QA experience in a pharma / API industry. Must have practical experience in either IPQA, Sampling, or ...
Posted 3 days ago
18.0 - 25.0 years
15 - 20 Lacs
chennai
Work from Office
Qualification & Experience: Qualification: M.Sc. Chemistry. Experience: 16- 25 years in Quality Assurance within an API or Bulk Drug Manufacturing environment. Must have prior exposure to USFDA and other international audits . Role & responsibilities Lead In-Process Quality Assurance (IPQA) activities across production and packaging areas. Ensure compliance with USFDA, WHO-GMP, MHRA, and other international regulatory requirements . Prepare, review, and approve QA documents SOPs, batch records, deviations, CAPA, and change controls. Plan and coordinate regulatory and customer audits , including audit readiness and follow-up actions. Conduct supplier audits and evaluate vendor quality systems...
Posted 3 days ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Job Responsibilities Ensure Quality Assurance, Quality Control, Microbiology, Production, Warehouse, Engineering activities are performed in compliance as per current GMP requirement and their effective implementation. Provide guidance to QA and cross functional department for compliance to various International CGMP requirements, Co-ordination with departments HOD to implement current GMP in Plant. Ensure execution and timely completion of Qualification and Validation Activities and their report Approvals for all the departments. Authorized documents but not limited to - Qualifications, Validation Protocols, Reports, all departments SOPs and level I documents for the plant. Authorized to re...
Posted 4 days ago
1.0 - 4.0 years
2 - 5 Lacs
satara
Work from Office
Role & responsibilities Line clearance certification during product changeover Proof checking of overprinted matter Review of batch manufacturing and batch packaging records Sampling of bulk finished and pack finished products Packline inspection and performing in-process checks Sampling of process validation, Hold time study. Monitoring of shopfloor activities through rounds, identification and notification of potential discrepancies Review of master batch documents, process flow and PVIA. Verification and authorization of EMRM and DPR. 2. Other activities Data logger placement and review of transit data. Review of Audit-trails of production equipment / instruments Placebo batch related act...
Posted 4 days ago
0.0 years
0 Lacs
india
On-site
Title: Sr Executive - Formulation Custom Field 2: 2750 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: FORMULATION DISINFECTANT Travel Description: Equipment Qualification IPQAPacking Validation
Posted 4 days ago
8.0 - 10.0 years
10 - 11 Lacs
vapi
Work from Office
Responsibilities: Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product. Review of raw material related documentation and release of raw materials Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPAs) Provide advice to departments regarding GMP compliance Review and approve QA controlled documentation such as SOPs, batch records, working instructions Assessing change control requests on consistency, relevance, GMP compliance and clarity Assist with writing, revising, and approving standard operating procedures. Review and preparation of batch release documentation Sup...
Posted 4 days ago
4.0 - 9.0 years
3 - 8 Lacs
vadodara
Work from Office
Role & responsibilities Ensure cGMP and regulatory compliance across all QA operations. Manage AQA, IPQA, batch release, deviations, CAPA, change control, and audits in line with quality standards. Oversee analytical data review and ensure strict adherence to data integrity principles (ALCOA+). Monitor on-floor QA activities, in-process checks, and documentation for accuracy and compliance. Maintain strong control over qualifications, preventive maintenance, and calibration reviews. Prepare quality documents independently as per regulatory and organizational requirements. Drive automation, digitalization, and continuous improvement initiatives. Preferred candidate profile M.Sc. Organic Chemi...
Posted 4 days ago
0.0 - 1.0 years
0 - 2 Lacs
bengaluru
Work from Office
Job description Onboarding date: Immediate Experience: ~1years Domain: Mechanical Engineering or related stream Work location: Bidadi Job Summary: We are looking for a proactive and detail-oriented Quality Engineer to join our team in the automobile industry. The ideal candidate will have strong technical knowledge of vehicle parts, hands-on experience in part inspection and quality control, and excellent English communication skills for effective coordination with internal teams, suppliers, and customers. Key Responsibilities: Conduct incoming, in-process, and final inspection of automotive parts and assemblies. Ensure that all components and assemblies meet defined quality standards and sp...
Posted 4 days ago
14.0 - 16.0 years
13 - 17 Lacs
bengaluru
Work from Office
1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...
Posted 5 days ago
7.0 - 12.0 years
2 - 6 Lacs
vapi
Work from Office
Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...
Posted 5 days ago
4.0 - 7.0 years
4 - 7 Lacs
hyderabad
Work from Office
Role & responsibilities 1. Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2. Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3. Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4. Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5. Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6. Responsible to Preparation &...
Posted 5 days ago
4.0 - 9.0 years
3 - 8 Lacs
bavla
Work from Office
Dear Candidate, Greetings from Intas Pharmaceuticals Ltd.! Intas Pharmaceuticals is a leading, vertically integrated global pharmaceutical company headquartered in Ahmedabad, India, with a strong presence in over 85 countries. Guided by innovation and a commitment to quality, Intas develops and manufactures affordable, world-class medicines to improve patient health worldwide. We are conducting a Walk-In Drive for experienced professionals in Quality Assurance IPQA (OSD) for our SEZ Plant . If you have hands-on experience in in-process quality assurance activities in Oral Solid Dosage (OSD) manufacturing, we invite you to join our growing team. Job Description: - Responsible for in-process c...
Posted 5 days ago
1.0 - 5.0 years
3 - 4 Lacs
vadodara
Work from Office
Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...
Posted 5 days ago
0.0 - 3.0 years
2 - 3 Lacs
ankleshwar
Work from Office
Responsibilities: Responsible for Documentation work in QC Department Candidate must have knowledge of HPLC & GC Responsible for manufacturing the batch as per MOM or BMR. Shall maintained all records related to manufacturing Overall looking after the complete filling, packing activities and Procurement of the packing material. To ensure the compliance of safety Requirement Cleanliness Hygiene and Environment in Working Areas. Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity. Required Skills: Must be excellent in written and spoken English; net savvy and adept at computer skills Attention for detail Team player Good in communication Req...
Posted 5 days ago
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