Piramal Pharma Ltd
Website:
piramalpharma.com
Job details:
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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
Deputy Manager-QA
Job Description
The Deputy Manager – Quality Assurance ensures compliance with GMP, regulatory, and internal quality standards in peptide manufacturing operations. The role involves batch release, review of executed batch records, and ensuring data integrity compliance. It includes managing QMS elements such as deviations, change controls, OOS/OOT, and CAPA. The position supports process validation, APR, and technology transfer activities while ensuring audit readiness. The role collaborates with cross-functional teams and external stakeholders to maintain high quality and compliance standards.
- Strong knowledge of peptide/API manufacturing processes.
- Experience in batch release management, ensuring compliance with regulatory and internal requirements.
- Review of executed batch records, including audit trail review for data integrity compliance.
- Preparation and review of Annual Product Reviews (APR) in line with regulatory expectations.
- Preparation and review of Process Validation protocols and reports.
- Review of technology transfer documents and data for completeness and compliance.
- Initiation, review, and management of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
- Oversight of dispatch activities and line clearance to ensure compliance with GMP requirements.
- Experience in cleaning validation, including protocol and report review.
- Conducting internal audits and ensuring timely closure of audit observations.
Annual Product Reviews, Audit Readiness, Process Validation, Quality Management Systems (QMS)
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