Manager - Quality Assurance

Brief Requirements:

• Should have faced International Audits.

• Should have been conducting audits of manufacturing locations & Vendors.

• Should have worked in shop floor and have sound process knowledge in manufacturing of Semisolid, Solid oral, Liquids & powder dosage forms.

• Should have thorough understanding of GMP guidelines and regulations applicable to Pharma, Personal Care, and food products.

• Should be well versed with ERP systems like SAP, LIMS, etc.

• Should have detailed process understanding and should have handled team directly.

Role Expectations:

• Should be able to lead the overall contract Mfg. activities for manufacturing of Pharma, Cosmetics & Food products.

• Should be able to review & perform critical activities on his / her own.

• Should be able to travel for GMP compliance and investigational audits.

S.No.RESPONSIBILITY

01

Responsible for implementing and ensuring Quality & Compliance at Contract Manufacturing Locations.

02

To ensure audits of CMLs, Vendors, external laboratories, are carried out and compliance is verified.

03

To ensure effective Quality Management systems like Change controls, Deviations, Out of Specification, Market complaints, Training, etc. are followed.

04

Responsible to ensure organisations Quality objectives are met & compliance is achieved.

05

Responsible to visit contract manufacturing locations regularly and to ensure risks are mitigated which may leading to non-conformances & product failures.

06

To ensure product failures, market complaints, non-conformances are investigated thoroughly, and compliance is maintained.

07

Responsible to ensure CAPA system and CAPA effectiveness is achieved.

08

Responsible to implement Quality rating system for contract manufacturing locations on ensuring performance of each site.

09

Ensure effective & timely escalations of failures with management and to address the issues.

12

Review and approval of SOPs and Validation Protocols & reports.

14

Review and approval of Master formula records (MFR’s), Batch manufacturing & packing records.

15

Review and approval of Batch manufacturing & packing records.

16

Review and approval of stability Protocols & reports

19

Coordination with CML, Vendors, External laboratories, R&D, Production & other concern personnel in meeting compliance activities.

20

Supervision and monitoring of day-to-day activities Quality assurance and to review the performance.

21

Training of subordinates & CML teams on good manufacturing practices, Data Integrity, Good laboratory practices.

22

Ensure monthly reports are generated and are reviewed.

23

Participate & conduct Quality review meetings on addressing the Quality Improvement Plan.