Job Description

Role & responsibilities

• Monitoring of Loan License Site located in Vapi/Palghar/Bhoisar.
• IPQA/Shop floor activities monitoring - Tablets, Capsules, Oral Liquids, External and Sterile formulations etc. (Preferred External preparations and Oral Liquid formulations)
• Quality Oversight at Loan License 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 profile

• Qualification: B. Pharmacy or M. Pharmacy Or any science graduate with relevant experience
• Thorough Knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations Handling of contract manufacturing Sites.

Competencies:

• 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.

More Info

Education