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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.

Liaise and build trusting and professional relationships with international pharmaceutical clients, healthcare professionals, internal and external stakeholders, including authors, reviewers, and key opinion leaders across therapeutic areas - learning to anticipate their needs. 

Expertise in compounding, aseptic operations, and troubleshooting the equipment, with a focus on solution-oriented approaches.

Candidate having experience of Bio-similar product manufacturing. Large scale bioreactor, Continuous centrifuge Trouble shooting, risk assessment, root cause analysis.

Perform chemical and physical analysis of raw materials, in-process samples, and finished products. Operate analytical instruments like HPLC, GC, UV Spectrophotometer, FTIR, Dissolution apparatus, etc. Conduct stability studies and routine sampling/testing as per SOPs.

Should have knowledge of country specific dossier preparation. Should have knowledge of country specific dossier preparation

BPharm, BSc, MPharm, MSc, MBBS, BAMS; Experience in PV/ Clinical Research drug safety preferred. Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.

Expertise in designing, executing, and reviewing cleaning validation protocols. ensuring compliance with cGMP. EMA. and other global regulatory requirements. Specializing in stability studies, regulatory compliance, and quality assurance oversight. Managing stability programs in alignment with ICH guidelines