7 - 10 years
5 - 9 Lacs
Posted:1 hour ago|
Platform:
Work from Office
Full Time
Monitoring of Contract manufacturers, Process Validation, Stability Study, Quality Agreement, APQR, FG Inspection and batch release.
Responsible of co-ordination with regional representative to harmonize Quality systems across all LLU Sites.
Quality Oversight at Contract manufacturing sites on periodic basis.
Protocol preparation and execution of process validation for all dosage forms-Pharma.
Stability Study and review of Stability Data as per stability interval.
APQR preparation, Witness manufacturing and analysis of finished product.
Execution of Quality agreements with all Contract manufacturing Sites.
FG Inspection, Review of batch records and Batch releases
Review of Finished product related data to support new Third Party Launch.
Quality Audits of Contract Manufacturers & compliance review
Monitoring of all shop floor activities & IPQA Checks - Tablets, Capsules, Oral Liquids, External & Sterile formulations etc.
Quality Indexing of Contract manufacturing Sites.
Good presentation skill for presentation of Quality review meetings.
CMO Management, co-ordination & Overall Quality compliance for LLUs
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.
B. Pharmacy
M. Pharmacy
Or any science graduate with relevant experience
Thorough Knowledge of shop floor of OSD & Sterile formulations
Handling of contract manufacturers LLUs
Shalina Healthcare
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