Manager - IPQA

Acme Generics Pvt. Ltd.; Solan; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

Acme Generics Pvt. Ltd. in India seeks a Quality Assurance professional to review and approve SOPs and BMR/BPR through the EDCS, and to approve Master Formula Records, APQR and IPQR.

Role Includes implementing SOPs on the shop floor, ensuring QMS compliance, IPQA line clearance, process validation, batch release via ERP/LIMS, cross‑functional coordination, and staff training on GMP/GDP.

Mansioni

• Responsible for review and Approval of Standard Operating Procedure (SOP) & BMR/BPR through EDCS.
• Responsible for review and Approval of Master Formula Record.
• Responsible for Approval of Annual Product Quality Review (APQR) and IPQR.
• Responsible for implementation and compliance of all SOP on shop floor.
• Responsible to ensure compliance of Quality Management System (QMS).
• Responsible for shop floor management w.r.t IPQA activities (Line clearance/In process control/In process sampling).
• Responsible for effective execution of Process Validation, Cleaning Validation and Hold Time activities.
• Responsible for approval of Bill of material through ERP software.
• Responsible for coordination with cross functional departments/sites for timely submission of documents to clients.
• Responsible for imparting training on SOPs, GMP and GDP.
• Responsible for review and approval of QMS documents through EQMS.
• Responsible to ensure stage wise release of batches through LIMS and ERP.
• Responsible to ensure the release of batches at QA level within required time for GB block.
• Responsible to ensure on line review of logs/books/BMR/BPR.
• Assist cross functional dept to complete investigations on shop floor.
• Self-Inspection or Internal Audit and its compliance.
• Ensure that products are manufactured as per approved Procedure.
• Review, implement and verify CAPA.
• Ensure work discipline in the department.
• Coordinate risk assessments per risk matrix.
• Handle CAPA investigations and market complaints.
• Online review of e-log entries daily.
• Handle Incident/Deviation change control and CAPA.
• Ensure entry/exit procedures, gowning and hygiene procedures are followed.

Descrizione del lavoro

Job Responsibilities:

1. Responsible for review and Approval of Standard Operating Procedure& BMR/BPR through EDCS.


2. Responsible for review and Approval of Master formula Record.


3. Responsible for Approval of Annual Product Quality review (APQR) and Interim Product Quality Review (IPQR).


4. Responsible for implementation and compliance of all Standard Operating Procedure on shop floor.


5. Responsible to ensure the compliance of Quality Management System as per the requirement.


6. Responsible for shop floor management w.r.t IPQA activities (Line clearance/ In process control/In process sampling).


7. Responsible for effective execution of Process Validation, Cleaning Validation and Hold Time activities.


8. Responsible for approval of Bill of material through ERP software.


9. Responsible for coordination with cross functional department / sites for submission of required documents to different clients in timely manner.


10. Responsible to imparting training on departmental SOPs, Good Manufacturing Practices (GMP) and Good Document Practices (GDP)


11. Responsible for review and approval of QMS documents through EQMS.


12. Responsible to ensure stage wise release of batches through LIMS and ERP software.


13. Responsible to ensure the release of batches at QA level within required time for GB block


14. Responsible to ensure on line review of executed log books, records and BMR /BPR.


15. Responsible to assist the cross functional department to complete the investigation related to shop floor.


16. Responsible for Self-Inspection or Internal Audit and its compliance.


17. Responsible to ensure that products are manufactured as per approved Procedure.


18. Responsible for review, implementation and verification of Corrective Action and Preventive Action (CAPA).


19. Responsible to Ensure work discipline in the department.


20. To coordinate perform the risk assessment of various areas as per the risk matrix.


21. Responsible for handling (Investigation and implementation of CAPA) of incident and market complaint.


22. Responsible for online review of e-log entries on daily basis


23. Responsible for Handling Incident/Deviation change control and CAPA


24. Ensure that the entry & exit procedures, gowning (Primary & Secondary, color code) procedures and Personnel Hygiene procedures are followed strictly.