April 2025

Sterile, parenteral operations including aseptic processing, filling, sealing, filtration, production, QMS, batch manufacturing, autoclave, terminal sterilization, and packing. Production lines : Ophthalmic, Vial, PFS, LYO, Cartridges, and Bag. Machine exposure: Groninger, Optima, Dyno Truking, Bosch filling machines, Fedegari sterilizer, Steriline, Plumat, Pharmalab, and packing and labelling machines.

Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.

Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners. 

Operational Excellence - Build on technical expertise, expanding it in complementary directions. Use technical expertise and creativity to proactively identify potential problems and address them using appropriate resources in discussion with team leads.

Perform monitoring and site management work to ensure that sites are conducting the studyies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor, co-auditor for outsourced parties CROs, Service Providers, Vendors, Affiliates & Partners etc., associated with Sun Pharma

Degree, Diploma in Pharmacy form recognized University. One Year experience in Managing Drug Store in reputed Hospital, Health Centre recognized by Govt. Candidate Should be well Conversant with Various Computer Programming include Excel, MS. Word, PPT and simple Statistical Package.

D.Pharm Siddha, Integrated Pharmacy Course for certificate issued by Government; District Tuberculosis Center and District Siddha Medical Units under the Nagapattinam District Health Association.

First Class Post-Graduate Degree in Life Sciences with PhD in Molecular Biology or Microbiology and strong background in Infectious Disease research. Prior experience in field sample collection, processing, documentation, record keeping and lab management would be an advantage.