Senior Executive-QA

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Piramal Pharma SolutionsPiramal 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-QAJob Description

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.

 Execution of Validation and Technology Transfer Activities:

• 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.

 Documentation:

• 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.

 Support for Technology Transfer and Validation:

• 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.

 Compliance and Quality Assurance:

• 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.

  Continuous Improvement:

• Identify opportunities for process improvement within validation procedures.

• Implement best practices & contribute to the enhancement of validation methodologies.

 

 Training and Development:

• Participate in training programs related to validation principles, practices, and regulatory requirements.

• Stay updated on industry trends and regulatory changes impacting validation activities.

 

 Other 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.