Senior Manager

4 weeks ago

Pithampur, India Unichem Laboratories Full time

RESPONSIBILITIES

  • Ensure All time Readiness for regulatory inspections by continuous monitoring of cGMP, GLP & Regulatory norms.
  • Ensure that systems, equipment, personnel, processes, analytical methods, cleaning method, utilities, facility etc are qualified/validated as per requirement.
  • Review and approve all master documents and records like SOP's, VMP, various validation protocols / reports. Master Production Records (MPR's), Batch Production Records (BPR's), Stability Protocol / Reports, Quality / Technical Agreements / APQR etc.
  • Ensure that document control and document retention is followed as per SOP
  • Perform self-inspection as per cGMP requirements and promptly reply to all inspectional observations of audits done by external agencies, customers and CQA.
  • Ensure that all committed compliances are completed within the committed timelines.
  • Provide prompt support to regulatory affairs by providing required reviewed data in a timely manner
  • Review and approve qualification protocols / reports (DQ/IQ/OQ/PQ) related to Quality Control instruments, manufacturing equipment, computerized systems, utilities etc
  • Approve/Reject the Finished API as deemed fit after necessary quality review and analytical records review.
  • Continuously improve the existing systems / procedures as per Quality System Guidelines issued by CQA and various international guidelines including ICH.
  • Prepare, coordinate and execute training schedule related to cGMP, GLP and SOP.
  • Ensure that all stability studies are carried out as per SOP/protocol and accordingly the shelf life of the marketed product is monitored on a continuous basis.
  • Review, approve / reject and close all Change Control / Deviation / records and ensure that required Corrective / Preventive actions are executed as identified in the concerned record.
  • Investigate Out of specification results, Market Complaints and deviations effectively, approve the CAPA and ensure that identified Corrective & Preventive actions are executed.
  • Formalize a system for quality risk identification / categorization and its mitigation.
  • Review and ensure that the preventive maintenance and calibration schedules are adhered to.

KEY SKILLS and COMPETENCIES

  • Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc.
  • Adequate experience of auditing API and Intermediate / KSM vendors.
  • Experience of working in API unit would be preferred.
  • Very good functional knowledge and application.
  • Proactive approach to internal and external queries.
  • Managing multiple stakeholders.
  • Should hold high standards of business ethics.
  • Excellent communication skills and decision-making skills.

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