Associate Manager -External Quality | Shalina Laboratories Pvt Ltd

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.