QA-Manager

☞ Leben Life Sciences

見る: 106

更新日: 06-05-2024

場所: Akola Maharashtra

カテゴリー: 生産/操作 薬剤師/薬剤師

業界:

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仕事内容

Manager- Quality Assurance :

1. To Lead QA team for Documentation, Qualification, Validation activities & creation

of QMS etc.

2. To Monitor trainings for all the employees directly associated with all manufacturing

team, responsible for Regulatory audits and for audit compliance report with handling

and closing

3. To Manage overall IPQA, Validation, Lab QA, QA Documentation & QMS activity

including change control, deviation, CAPA, Lab Incident, OOS, OOT, QRM, Market

complaint, Product recall, Mock recall of the plant.

4. To Work with Technical Director to create a highly compliant environment that

produces quality products.

5. To Evaluate batch manufactured & test records & processes, systems, procedures,

Compiling, investigating and finding root cause of any product quality failures along

with ensuring CAPA and its compliance for same.

6. To Conduct internal audits for all department in plant and to ensure quality of QMS

system in other department i.e Production, Warehouse, Engineering & QC, HRA and

IT.

7. Responsible for Approval & compliance of Standard operating procedure, Approval

of BMR, BPR,APQR, all QMS documents.

8. To check the work activities and documentation related to QC & Micro Labs and

ensure the compliance of cGLP including review of stability studies data, Reserve

samples etc.

9. To Review and Approval of Apex document like SMF, VMP, Quality Policy ,Quality

Manual, Data integrity Policy and finalized all company policies.

10. To ensure compliance of training of cGMP (Current Good Manufacturing Practice)

practices and GDP (Good Documentation Practices) and Data integrity.

11. To audit the vendors as per scheduled and and ensure audit compliance report and

closing. Compliance of audit report and Vender management including inspection of

vendor and approved the vendor list.

12. To approved annual training schedule of all department.

13. To approved /reject finish product release note for batch release/reject in ERP system.

14. Approval/Rejection of Artwork approval sheet and shade cards

15. To Approve item code and Product code to raw material and finish products

respectively

16. Approval of all Master Specification documents like TDS, STP.(RM,PM,FP) etc.

Highest Qualification: B.Pharm / M.Pharm / M.Sc

Experience: 8+ Years In Pharma formulation.(Regulated market exp. Will be

preferred)

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締切: 20-06-2024

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