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Manager

10-15 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B. Pharm / M/Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager

Date: December 28, 2024

Location: Aurangabad, Maharashtra, India

Company: Lupin


Role Description:

The Manager for Investigation will be responsible for overseeing the investigation functions at the site, ensuring compliance with cGMP, GxP, and other regulatory requirements. This role involves close collaboration with various functions within the organization such as Quality Assurance, Quality Control, Manufacturing, R&D, and Corporate QA. The Manager will lead and guide investigation teams to ensure proper Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and timely closures of investigations related to Out of Specification (OOS) results, Out of Trend (OOT) data, deviations, and market complaints.


Key Deliverables:

  1. Compliance Management:

    • Ensure compliance with cGMP, GxP, and regulatory requirements, including EH&S (Environmental, Health, and Safety) regulations.
    • Ensure self-training and monitor team member training on relevant SOPs (Standard Operating Procedures).
  2. Investigation Management:

    • Lead and supervise the site investigation team to handle investigations for OOS, repeat OOT, deviations, and market complaints.
    • Lead major/critical investigations and ensure timely and appropriate closures.
    • Analyze and share weekly/monthly reports on investigations, focusing on key findings, CAPA effectiveness, and trends.
  3. Trend Analysis and Improvement:

    • Analyze historical data to derive trends in findings, quality concerns, or areas for improvement and notify management.
    • Mentor SIT (Site Investigation Team) members to improve their investigation skills and identify areas for improvement.
  4. Training and Development:

    • Conduct training programs on technical and GMP-related topics for team members.
    • Review and improve the quality of investigations and technical report writing within the team.
  5. Regulatory Support:

    • Provide support during regulatory inspections, audits, and third-party/vendor inspections, specifically related to investigations.
    • Ensure compliance with QAMS (Quality Assurance Management Systems) documentation related to investigations, deviations, OOS, OOT, LIR, market complaints, change controls, and CAPA.
  6. Continuous Improvement:

    • Support the implementation of investigation management formats, matrices, and continuous improvement initiatives.
    • Participate in cross-functional teams for process improvements.

Key Customers:

  • External:

    • Corporate Quality Assurance
    • Regulatory Bodies
  • Internal:

    • Quality Assurance
    • Quality Control
    • Manufacturing
    • Engineering
    • Regulatory Affairs
    • PDL
    • R&D

Customer Expectations:

  • External:

    • Ensure all regulatory and statutory compliance.
    • Conduct robust investigations and ensure timely and accurate resolution.
  • Internal:

    • Active participation in investigations.
    • Timely closure of investigations with comprehensive RCA and CAPA evaluation.

Education Qualification:

  • B. Pharm / M. Pharm

Relevant Work Experience:

  • 10 to 15 years in pharmaceutical quality assurance, regulatory compliance, or a related field with experience in leading investigations.

This role offers an opportunity to be part of Lupin's dynamic quality management team, focusing on continuous improvement and ensuring compliance across all manufacturing and regulatory activities. If you have the relevant experience and qualifications, apply now to contribute to Lupin's success.