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Sterile Production - Sr. Executive
Location: Bharuch , Ankleshwar (Gujarat)
No. of Openings: 2
Qualification: B. Pharm or M.Pharma or M. Sc, chemistry
Experience: Minimum of 5 years in the Production department, specifically in Aseptic/Sterile operations
Salary: 10Lpa
Industry: Pharmaceuticals
Job Description:
Key Requirements
Technical Expertise:
- Proficiency in operating equipment such as Steam Sterilizer, Autoclave, Reactor, Filter Press/CF,VHP, Homogenizer, Dry Heat Sterilizer, Washing Machine, Filling Machine, WFI system etc.
- Understanding of Process Validation for Sterilization, Washing, Aseptic Filling, and Cleaning Procedures.
- Knowledge of performing process performance qualification.
- Proficiency in equipment qualification.
Regulatory Knowledge:
- Competence in evaluating and managing change controls, deviations, incidents, out-of-specification (OOS), out-of-trend (OOT), and risk management processes.
- Hands-on experience with regulatory audits, including US-FDA, UK-MHRA, ANVISA-Brazil, TGA-Australia etc.
Documentation & Training:
- Ability to prepare SOPs, qualification protocols, and various study protocols.
- Proficiency in conducting investigations and preparing comprehensive reports.
- Strong knowledge of GMP practices with the capability to train relevant personnel.
Process Improvement:
- Familiarity with aseptic processes, Lean methodologies, OEE, and other key performance indicators.