Manager - Quality Control

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager - Quality Control

Job Description

Ensure analysis of Semi Finish Product, Stability samples, Validation and Blend Samples and related documentation as per cGMP requirement

Key Roles/Responsibilities:

 

1.     Ensure analysis of Semi Finish Product, Stability samples, In Process and Blend Samples and related documentation as per cGMP requirement.

2.     Ensure entry of data in SAP and release of semi-finished products in SAP.

3.     Plan the Analysis of Finish Product and stability samples as per cGMP requirement in time.

4.     Allocation of work as per the skills of persons and supervision.

5.     Review and approve OOS, OOT and Incident of QC laboratory and carry out OOS investigation.

6.     To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia     changes like IP, BP, USP, Ph. Eur, JP etc.

7.     Review of work output and pending work.

8.     To perform self-audit of QC Laboratory on periodic basis.

9.     Ensure analysis of Raw Materials / Finished Products as per requirement from Outside Commercial Lab.

10.   To check audit trail in QC Instruments.

11.   Ensure compliance to KRA’s and other such assignments.

12.   To control and maintain QC Laboratory Records. (Like Laboratory note Book, Chromatograms, and COA etc.).

13.   On job training as necessary to develop skills and improve productivity.

14.   To ensure cGMP in quality Control laboratory.

15.   Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.