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Assistant Manager - Production Compliance

Early Applicant
  • Posted a month ago
  • Be among the first 10 applicants

Job Description

Roles and Responsibilities :-

  • Overall responsible for cGMP compliance of the production functions at shop floor of OSD, Injection and Oral Liquid area.
  • Ensure the online documentation on the shop floor i.e. BMR and BPR.
  • Ensure the online documentation on the shop floor i.e. usage logbook of process equipment.
  • Ensure the online documentation on the shop floor i.e. cleaning logbook of process equipment.
  • Ensure the online documentation on the shop floor i.e. cleaning logbook of area.
  • Ensure the online documentation on the shop floor i.e. environmental monitoring record.
  • Ensure the proper labelling on the process equipment's & instruments for preventive maintenance, calibration, qualification, cleaning & status labelling.
  • Responsible for the review and assessment of cGMP document such as SOPs.
  • Ensure and compliance of SOPs for operation, cleaning, preventive maintenance and calibration of process equipment / instruments and equipment usage logbook with respect to actual practices.
  • Review of audit trail of process equipment / instruments.
  • Review the equipment operation as per the Equipment qualification protocols / reports,
  • Review the manufacturing activity of the products as per the Process validation protocols / reports.
  • Review and assessment of QMS documents i.e. deviations, OOS/ OOT, incident, change control, non-conformance, CAPA, market complaint, product recall, etc.
  • Responsible for review of Risk Assessment related to production department.
  • Responsible for performing the self-inspection in the production departments.
  • Review cleaning of the area & equipment as per the cleaning validation documents.
  • Responsible for the review and assessment of shop floor activity.
  • Responsible for the verify the training documents of production persons.
  • Responsible for the verify the F&D related documents.
  • Responsible to provide trainings on data integrity & current established guidelines by different regulatory authorities.
  • Responsible for complying with the provisions of the current pharmaceutical regulations and fully implementing the cGMP requirements at the plant.

Candidate Profile Required :-

  • Candidate must have the regulatory exposure of the EU/ MHRA/ USFDA audits
  • Experience should be 10-12 years
  • B Pharmacy /M Pharmacy
  • CTC 8-9 Lakhs OR Negotiable
  • Immediate Joiner

More Info

Industry:Other

Function:Pharmaceutical

Job Type:Permanent Job

Skills Required

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Date Posted: 31/12/2024

Job ID: 103874047

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