Job Description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager - Quality Assurance

Job Description

• Maintenance of Validation Master Plan, CMP & CML.
• Planning of validation/qualification/CSV activities as per VMP.
• Preparation and review of protocols for Equipment qualification, Computer System Validation, Area and HVAC qualification, Utility Qualification including temperature mapping for new projects and as per VMP.
• Review of protocols for Process Validation, Cleaning Validation activities and BMR /BPR as and when required.
• Review of Standard operating procedure in Ensur.
• To Coordinate with cross-functional teams and customers for timely completion of validation activities.
• To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities.
• Review of executive summary reports for trends of Water and Area monitoring results, To perform the IT Supplier Assessment, Periodic review, and Audit trail review.
• To carry out the On-Boarding, training, and Off-boarding of service staff provided by the Vendor/Supplier Organization.
• Handling of Audits, Internal as well as external.
• To provide compliance against audit findings and to ensure appropriate corrective actions based on audit findings.
• To impart training to team members / other concerned personnel / new employees on SOPs, on-job training, cGMP, 21 CFR & other regulatory requirements.
• Handling of Track Wise activities (review & approval of change controls).
• Handling of Ensur-related activities (Initiation & review of documents).
• Handling of QMS Activities (Change control, Incident, Deviation, CAPA and Investigation etc.).
• Maintaining documents as per site procedures, Archival, and disposition of documents.
• Review of media fill activity and personnel qualification activity.

· Maintenance of Validation Master Plan, CMP & CML.

· Planning of validation/qualification/CSV activities as per VMP.

· Preparation and review of protocols for Equipment qualification, Computer System Validation, Area and HVAC qualification, Utility Qualification including temperature mapping for new projects and as per VMP.

· Review of protocols for Process Validation, Cleaning Validation activities and BMR /BPR as and when required.

· Review of Standard operating procedure in Ensur.

· To Coordinate with cross-functional teams and customers for timely completion of validation activities.

· To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities.

· Review of executive summary reports for trends of Water and Area monitoring results, To perform the IT Supplier Assessment, Periodic review, and Audit trail review.

· To carry out the On-Boarding, training, and Off-boarding of service staff provided by the Vendor/Supplier Organization.

· Handling of Audits, Internal as well as external.

· To provide compliance against audit findings and to ensure appropriate corrective actions based on audit findings.

· To impart training to team members / other concerned personnel / new employees on SOPs, on-job training, cGMP, 21 CFR & other regulatory requirements.

· Handling of Track Wise activities (review & approval of change controls).

· Handling of Ensur-related activities (Initiation & review of documents).

· Handling of QMS Activities (Change control, Incident, Deviation, CAPA and Investigation etc.).

· Maintaining documents as per site procedures, Archival, and disposition of documents.

· Review of media fill activity and personnel qualification activity.