Senior Manager - Corporate Quality Assurance

About the Company

Glenmark is committed to delivering high-quality pharmaceutical products and services. Our mission is to enhance the quality of life through innovative healthcare solutions, and we foster a culture of integrity, collaboration, and excellence.

About the Role

The role involves reviewing Quality Management System (QMS) documents and participating in investigations related to microbiology, incidents, and market complaints across Glenmark's parenteral drug manufacturing sites.

Responsibilities

• Review of QMS documents like OOS associated with Microbiology, Incident / Investigation and Market Complaints across Glenmark parenteral drug manufacturing sites.
• Review of investigation data for completeness and reliability. Taking active participation for investigation and root cause analysis.
• Timely escalations of the various investigations to Steering committee.
• Enhance the closure rate of QMS elements and reduce number of overdue QMS element.
• Reviewing the adequacy of CAPAs with respect to the root cause investigations and to verify the CAPA Effectiveness check is well defined. Reducing repetitive failure and remediating product by improving process or analytical issues. Usage of statistical investigation tools for investigation. Improving compliance by 25% YoY basis.
• Review of CAPAs for global implementation.
• Able to identify and notify atypical product trends while review of investigations, ensure appropriate and effective CAPAs are implemented to reduce re-occurrence.
• Provide response and compliance to internal as well as external audit observations associated with investigation. Support site for regulatory response/compliance associated with manufacturing process/Microbiology and validation.
• Ensure the adequacy of investigation cycle with its key components such as Root cause, CAPA, Impact assessment as per Policy and regulatory expectation.
• Evaluation of CAPA which should be having direct linkage to Root cause and ensuring whether CAPA is specific to product or required extrapolation to other products.
• Ensuring the Effectiveness plan is supported by root cause identification and having appropriate method and frequency of monitoring to establish its effectiveness.
• Reviewed Investigation data should be in sequential order (As per investigation cycle). Data status should be having clarity on validated/invalidated results. Data attributed to hypothesis/repeat and their reference as supporting or reportable should be supported by outcome at each phase of investigation.
• Verification of site practice against global audit observation and proposal of implementation if any.
• Comparison of site trend on failure investigation and notifying any adverse/emerging trend of site.
• Escalation of failure investigations outcome and reoccurrence pertaining to product and quality system to committee.
• Part of internal audit for continuous improvement of parenteral drug manufacturing process, process qualification and quality function.

Qualifications & Experience

M. Pharm / MSc in chemistry

12 to 15 years total experience in the Pharmaceutical Industry

Required Skills

• Strong knowledge of Quality Management Systems (QMS) including OOS, OOT, Deviations, Incidents, Investigations, CAPA, and Market Complaints.
• Experience in parenteral drug manufacturing and aseptic/sterile operations .
• Good understanding of microbiology , contamination control, and EM/sterility trend interpretation.
• Proficiency in root cause analysis tools (Fishbone, 5 Whys, FMEA, Fault Tree Analysis).
• Ability to analyze investigation data, statistics, trends , and atypical product behavior.
• Strong expertise in CAPA evaluation , global CAPA implementation, and effectiveness checks.
• Familiarity with regulatory guidelines (USFDA, MHRA, EU GMP, WHO, PIC/S , Annex 1).
• Experience in audit preparation , response writing, and addressing regulatory observations.
• Excellent documentation and scientific writing skills for investigations and impact assessments.
• Ability to identify emerging trends and escalate failures based on quality risk.
• Skilled in cross-functional collaboration with manufacturing, QC, QA, RA, and global teams.
• Strong decision-making , risk-based judgment, and timely escalation capability.
• Excellent communication, analytical thinking, and problemsolving skills.
• Experience with QMS/eQMS tools (TrackWise, Veeva, or equivalent).
• Proficiency in MS Office tools (Excel, PowerPoint, Word).

Pay range and compensation package

Pay range or salary or compensation details are not specified in the provided job description.

Equal Opportunity Statement

Glenmark is an equal opportunity employer committed to diversity and inclusivity in the workplace. We celebrate differences and strive to create an inclusive environment for all employees.