AGM/DGM Production | Goa | Indoco Remedies

Job Description

  • 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

 

Location