Senior Executive-QA

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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
• Senior Executive-QA

To perform Technology Transfer and Validation activities. To prepare, execute documents and to complete the related activities / documentation in accordance with cGMP requirements.

Planning And Strategy

• Assist in developing Technology Transfer, Validation strategies and plans for new processes, systems, and products.
• Ensure alignment with regulatory requirements and industry standards.

• Coordination with different departments for performing Technology Transfer, Validation activities and for preparation of BMR/BPR and Execution of validation activities as per VMP.
• Coordinate and perform Technology Transfer and Validation according to approved protocols and schedules.

• Preparation & review of SOPs, Batch manufacturing records, Batch Packaging records and supporting documents.
• Preparation and review of protocols and reports for Optimization, Submission and Validation, Cleaning validation and hold time.
• Maintain accurate and complete validation documentation, including protocols, reports, and validation summaries.
• Preparation & review of risk assessment of process, and product etc.
• Preparation and execution of temperature excursion and Transportation study of product.
• Review of BMR, BPR for their correctness & completeness.

• Assisting and supervising Technology transfer and validation projects from initiation through completion.
• Coordinate with cross-functional teams (e.g., Manufacturing, QC, QA, warehouse & Engineering) to ensure timely completion activities.

• Ensure compliance with regulatory requirements and company quality standards.
• Participate in internal and external audits related to validation activities.
• Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.

• Identify opportunities for process improvement within validation procedures.
• Implement best practices & contribute to the enhancement of validation methodologies.

• Participate in training programs related to validation principles, practices, and regulatory requirements.
• Stay updated on industry trends and regulatory changes impacting validation activities.

• To handle the SAP Related Activities (creation item codes, review, updation of BOMs in SAP system etc).
• Handling of ENSUR & TRACKWISE related activities (Initiation / training of documents)
• Maintaining documents as per site procedure, Archival and disposition of documents.
• To ensure the EHS (Environment, health, and safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as per EHS requirement.
• Handling/ execution of other job as per the instructions of the superiors.