Executive /Sr. Executive – CQA – Loan Licencing

3 days ago

Palghar Vadodara, India Shalina Healthcare Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Monitoring of Loan Licence Site located in Palghar & Vadodara region.

IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred Tablets, Capsules, Oral Powder formulations)

Quality Oversight at Loan Licence Sites and tracking for closure of actions.

FG Inspection, Review of batch records and Batch releases.

Site pre-assessment for regulatory inspections as per GMP requirement.

Investigation of any non-compliance in co-ordination with LLU Site and tracking closure of CAPA.

Review and COA and analytical data before release of finished product from LLU Site.

Review of Finished product related data to support new product Launch.

Process Validation and Stability study execution and data review at LLU.

APQR preparation, Witness manufacturing and analysis of finished product.

Quality Audits of Contract Manufacturers & compliance review

Overall LLU Management & co-ordination.

Preferred Candidate:

Candidate should have good exposure to GMP environment and regulatory inspections.

Candidate should be flexible for business travelling across India & Overseas Locations

Candidates working on Shop floor and should have good GMP/GLP exposure.

Independent and Candidates who able make to decisions online.

Cross functional working and good ability to communicate with external stakeholders.

Qualification:

B. Pharmacy

M. Pharmacy

Or any science graduate with relevant experience

Competencies:

Thorough Knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations

Handling of contract manufacturing Sites.

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