Executive - QA

3 days ago

Ankleshwar, India Zentiva Group, a.s. Full time

**Education**:

- Graduate / Post Graduate in Pharmacy or Chemistry
- Experience:

- 03-04 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
- Quality Management/Continuous Improvement
- Handling of Deviations & CAPA
- Handling of Product Technical Complaints
- Review of Master Batch Manufacturing & Packing Records
- Release / rejection of Finished Products
- Management and Control of Documents, such as SOPs, Master Documents
- Issuance of BMR/BPR, log books and other controlled documents
- Management of Documentation room
- Preparing & review the Annual Product Quality Review
- Batch Rework/Reprocessing (Coordination from QA point of view)
- Coordination of cGMP Training activity including training of the people
- Handling of returned goods (Coordination from QA point of view)
- Handling of Self inspections
- Compliance to EN ISO 13485 requirements
- Validations & Qualifications:

- Preparation of Validation Master Plan
- Ensure validated status of all equipment, manufacturing processes, and cleaning processes
- Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning
- Review of protocols for qualification and validation of facility/ equipment / product / process
- Review and certification of validation reports after execution of validation of facility /equipment / product / process
- Sampling activity for validation batches
- Compliance:

- Ensure adherence to company Quality Standards, EU regulations and Local FDA regulations, by
- understanding the requirements
- Performing the Gap analysis to find out the gaps in existing system
- Preparing a compliance plan for closure of gaps
- Execution of compliance plans
- Review of completion of compliance activity
- Prepare for and attend to external / regulatory Quality audits
- Assuring quality of products by:

- Ensuring SOP review and compliance
- Management of Events
- Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
- Investigation of deviations & Customer complaints
- Review of executed Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
- To approve the line clearance in manufacturing & Packing
- cGMP Training:

- To develop training modules and organize training in GMP
- Develop and execute the overall training program in coordination with all concerned departments
- Other:

- Implementing the pest control program as and when required
- Review of maintenance and calibration program and calibration documents
- Review of quality control documents
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

  • Executive - QA Packaging

    1 week ago

    Ankleshwar, India UPL ltd Full time

    **Executive - QA Packaging**: - Job Id: 6428- City: Ankleshwar, Gujarat, India- Department: Quality Assurance- Function: SCM- Employee Type: Permanent Full Time- Seniority Level: Executive- Description: - This position is responsible for QA packing inspection. Makor responsibilities include: 1. Undertake incoming PM inspection as per AOL 2. New Product...

  • Executive QA-api

    1 day ago

    Ankleshwar, India Sensys Technologies Pvt. Ltd Full time

    We are hiring QA executive. Experience - 4 or 5 years only pharma line **(API experience )** Qualification - bsc / msc chemistry Salary - 4 to 5 lakh **no more than this P. A** Location - Ankleshwar Only male **RESPONSIBILITIES**: - To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish...

  • QA Executive

    2 weeks ago

    Ankleshwar, India Dreams Management Full time

    Key Skills -: - Qualifications -: - Bsc / Msc chemistry - Experience Required (Years) -: - From 4 To 5 Years - Salary Range (PA) -: - 400000 To 500000 - Location -: - Ankleshwar - Industry Type -: - Chemical Company - Job Description - 1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material,...

  • QA Executive

    1 week ago

    Ankleshwar, India Basic Pharma Life Science Pvt. Ltd. Full time

    Educational Qualification: M. Pharm (Q.A.) - Experience: 2 to 3 years in **pharma API** Plant. - Knowledge of QMS documentation like Change Control, Deviation, CAPA, APQR, Preparation and review of BMR, Process Validation, Qualification of equipment's etc. **Salary**: ₹18,000.00 - ₹25,000.00 per month **Benefits**: - Health insurance - Provident...

  • Executive - QA Packaging

    1 week ago

    Ankleshwar, India UPL NA Inc. Full time

    Job Id: 6428- City: Ankleshwar, Gujarat, India- Department: Quality Assurance- Function: SCM- Employee Type: Permanent Full Time- Seniority Level: ExecutiveDescription: This position is responsible for QA packing inspection. Makor responsibilities include: 1. Undertake incoming PM inspection as per AOL 2. New Product Development. 3. To ensure SAP & LIMS...

  • Ztmp QA

    1 day ago

    Ankleshwar, India Zydus Group Full time

    Department - ANKLESHWAR QA -U2 - Job posted on - Feb 12, 2025 - Employment type - C-C8-Confirmed-HO Executive Total Experience: Min. 03 years - Preparation and Review of APQR - To verify implementation of recommendations. - Handling of software qualification activity at site. - Preparation, review and control of quality document management system - To...

  • QA Officer

    3 days ago

    Ankleshwar, Gujarat, India Dolphin chem Full time ₹ 2,40,000 - ₹ 3,60,000 per year

    Sampling of materials as per defined sampling scheme.Issuance, control and retrieval of controlled documents.Control sample management.Review and release of raw material, packing materials and intermediates for further use.To perform IPQA activities at shop floor in each and every stage of manufacturing and packing.Review of documents of respective areas and...

  • QA Executive @ Pharma Unit

    2 weeks ago

    Ankleshwar, India U V Pharma Full time

    1. To review the QA SOPs with the guideline requirements. 2. To release the product to customer in the absence of head QA. 3. To arrange for the preparation of the training schedule by coordinating with Production, Store/ Warehouse, QC dept. etc. 4. To prepare and review the annual product review. 5. To issue change control form, reviewing the change...

  • Ztmp QA of Qc

    1 day ago

    Ankleshwar, India Zydus Group Full time

    Department - ANKLESHWAR QA -U2 - Job posted on - Feb 12, 2025 - Employment type - C-C8-Confirmed-HO Executive Total Experience - Minimum 4 Years - Person from background of**Quality Control**department**will be more preferable. - Responsible to ensure Good Laboratory Practices & compliance of QC SOP. - Responsible for reviewing and approving the analytical...

  • Ztmp QA

    1 day ago

    Ankleshwar, India Zydus Group Full time

    Department - ANKLESHWAR QA -U2 - Job posted on - Feb 12, 2025 - Employment type - C-C8-Confirmed-HO Executive - Total Experience - More than 3 Years - Qualification - Msc Chemistry - Responsible to perform activities comes under the IPQA. - Maintaining the softcopies of scanned master Batch record folders for routine issuance activities. - Preparation,...