- Bachelor in Pharmacy with more than 15 years of experience in pharmaceutical production of small volume and large volume parenteral with proven experience in taking a facility from installation to commercial operation stage with USFDA and EUROPE Regulatory Approvals
- Expertise in handling all troubleshooting related to Production processes.
- Handling Production block independently – operation, maintenance, administration
- Expertise in new product transfer from FDD, and execution of exhibit batches.
- Expertise in simplification of GMP documentation, such as SOP, BMR, and Protocols
- Expertise in Quality management systems such as Investigation, root cause, and CAPA.
- Handled Liquid aseptic flled products, suspension products, and terminally sterilized products in various packs i.e. Vial, Ampoule, PFS.
- Extensive experience in the production of injectables like Preflled syringes, Ophthalmic (3 Pieces), Vials, Liquid, and Ampoule.
- Product handled: – General Injectable, Ophthalmic.
- Planning to achieve the targeted volume production as well as achieving maximum asset utilization and labor productivity.
- Adopt implementation quality systems.
- Proficient in resource planning, and development for ensuring seamless production operations
- Well versed with various GMP guidelines & secured FDA approval in injectable manufacturing. Major regulatory audit exposure like USFDA, MHRA, WHO, ANVISA, TGA, SAHPRA, etc
Qualification & Experience:
Candidates should be B. Pharma / M. Pharma with a minimum of 15 years in sterile and injectable production.
Key Skills and Competencies:
- Must have exposure to regulatory inspections like USFDA / WHO-GMP / EU
- Good communication & leadership skills
- Strong technical skills
- Good administration skills