Glenmark Pharmaceuticals Job vacancy – Submit Resume

Role & responsibilities

Overall responsibilities with respect to management of audit program from Corporate for all sites of Glenmark. Effectiveness of Audit program to act as a proactive tool to prevent significant observation in regulatory audits.

• Management of Internal audit program from Corporate for all sites of Glenmark.
• a. Preparation and approval of Internal Audit planner.
• b. Execution of Audits as per the planner
• c. Selection of Auditors for conducting the audits.
• d. Conducting timely Audits.
• e. Sending Audit reports and receiving responses.
• f. Compliance verification of Audits.
• g. Closure of Internal Audits. Follow up for CAPA implementation.
• h. Extension of one site CAPA to other sites as a global CAPA approach.
• i. Effectiveness verification of CAPA through Internal Audits.
• j. Maintenance of documents related to all Internal audits. Audit as per approved Audit plan. Selection of Authorized auditor. Timely verification of compliance. Implementation of CAPA. Extension of CAPA to other sites.
• Effectiveness of Internal Audit program to act as a proactive tool to prevent significant observation in regulatory audits.
• Preparation & classification of all external and internal audit observations based on USFDA six systems model. Preparation of outcomes for continuous improvement of Quality Systems for entire Glenmark and derive improvement plans for each site (every month ppt with stake holder for discussion)- 483’s and W/L effectiveness. Implementation of Corporate QMS guidelines to all sites. Verification of compliance reports and its CAPA
• Knowledge of Microbiology Lab practices, Aseptic media fill validation.
• The candidate will have experience in sterile operation being directly involved in validation of PFS , Vial filling line and lyophilization line Actively participated in EMPQ and medial fill simulation studies

Preferred candidate profile

Candidates from Sterile pharma background will be preferred. Must have Internal Audit experience, USFDA exposure.

Interested candidate can share their updated resume on prachi.jain1@glenmarkpharma.com with subject line as “Application for Internal Audit, CQA”