Deputy Manager- CQA(Formulation)

Job Title: Deputy Manager- Formulation

Location: Govandi, Mumbai

Department: Corporate Quality Assurance

Qualification, Experience and Technical Competency:

1. Master’s Degree in Pharmacy or Science or equivalent scientific field.

2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of

Formulation industry with 2 to 3 years experience in Quality Control.)

3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP)

4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management

Systems (QMS) and regulatory guidelines.

Key Requirements:

Responsible for Quality Functions across Own Sites and Contract Sites with adherance to

cGMP, Regulatory standards and internal quality policies

1. Quality Management System (Own Sites and Contract sites):

Review Change controls, deviations, Out of Specifications (OOS), Out of Trend

(OOT), Incidents for continous improvement.

2. Product Documentation, Qualification and Validation Documents:

Review Master and Executed batch Records, Analytical records, Annual Product

Quality Review, Area Qualification, Process and Analytical Validation Documents

3. Corporate SOP’s:

Prepare Corporate SOPS to ensure implementation of quality systems across Own Sites

and contract sites.

4. Regulatory Compliance across Sites & CNFs through Audits/ Site Visits:

Conduct Self Audits at Own Sites and R&D laboratories to ensure Regulatory

Compliance.

Ensure all sites comply with global regulatory requirements (USFDA, MHRA, WHO,

ICH) through Site visits.

5. Complaint Investigation

Investigation of complaints and ensure effective CAPA implementation across sites

with complaint closure.

6. Vendor Qualification:

Support Vendor Qualification for new/alternate vendors for Raw materials and

Packaging materials through review of vendor documents.

Conduct Vendor Audits as per schedule and ensure timely submission of audit report

and review audit compliance reports.

7. Technology Transfer:

Support for Technology Transfer and Process Validation of New/ Existing Products at

Contract Sites.

8. Co-ordination with Croos Functional functions (Regualtory Affairs, Supply chain,

R&D Marketing) to resolve technical queries for quality compliance.