Job Overview
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Date PostedOctober 14, 2022
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Location (State / UT)
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Expiration date--
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Experience15 Years, 22 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Job Responsibilities :
- Ensure all activity related to the administrative and technical functions of the department are carried out as per schedule & approved procedure.
- To control & improve the aseptic practices & behavior in routine activity.
- To plan and execute the monthly production and raw materials & packing materials
Requirement schedule.
- To follow the safety norms and cGMP procedures.
- To Handle & support the activities required for internal and external audits including regulatory audits.
- To respond to the observations observed by auditors during inspections.
- Review and handling of Change Controls, Deviations, Incidents, Customer complaints, OOS, and CAPA. etc
- Review of Qualification (Equipment, Area, Utility), Cleaning, and Process Validation documents and ensure completion of activities as per schedule/Planner.
- Review of documents related to GMP, SOPs, Operating manual, and Batch records.
- Technology transfer support to F&D and Regulatory support for submission-related tasks.
- Water system, Environment monitoring report review and take necessary action for any failure.
- To ensure implementation of c-GMP, GEP, and Quality Systems.
- To ensure cost control in the area of manufacturing expenses, waste, and downtime reduction.
Desired Candidate Profile
Reporting To: CEO
Geographic Location: Sachana, – Viramgam, Gujarat, India
Qualification: B. Pharm/M. Pharm/M.sc
Experience
Minimum 15-22 years of experience in the Production of sterile/parental, ophthalmic as per the guidelines of the regulated market
Team size 100 + (Manufacturing Team + Engineering Team + Stores)