Head Quality

Role & responsibilities

You will be working as Quality Head as DGM/GM for EU, MHRA etc approved Formulation

Semi Solids & Liquid Oral manufacturing company based at Palghar/Tarapur.

Will be responsible for:

1. He will Lead Quality function for their Tarapur site .

2. He will be responsible for handling, developing, implementing, and maintaining a

comprehensive quality management system (QMS) elements including :

• Deviation, Change Control, CAPA, and OOS management

• Quality Risk Management

• Document and Record Control

• Annual Product Review (APR/PQR)

• Vendor Qualification and Audits

3. You will be responsible for ensuring that all pharmaceutical manufacturing equipment and

facilities are appropriately qualified and validated.

4. You will be responsible for reviewing and approving SOPs for manufacturing, quality

control, and other relevant departments.

5. You will be handling all Regulatory Audits start to end, including, EU, MHRA , TGA,ROW

etc.

6. You will be work closely to with Production, QC, Engineering, Regulatory Affairs, and R&D

teams and Support in technology transfers, process validations, and new product

introductions from QA perspective.

Preferred candidate profile

1. Candidate should have a M.Sc Chemistry or B.Pharm/M.Pharma with Minimum 15-20

years of experience in the pharmaceutical industry with at least 5 years in a senior QA

leadership role in a regulated environment in Semi Soilds & Liquid oral dosage form.

3. Candidate should handle key performance indicators (KPIs) to measure and report on the

effectiveness of the quality assurance program.

4. Candidate should have knowledge of pharmaceutical regulations, particularly GMP , ICH ,

WHO requirements.

5. Candidate should be good in timely resolution and documentation of OOS/OOT

investigations and QMS .

6. Candidate should be good in handling Conduct internal audits and inspections to identify

and address compliance issues.