Piramal Pharma Ltd
QA Officer
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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
QA Officer
Job Description
The Quality Assurance officer will act as the Quality Assurance representative for campaign projects, ensuring accuracy and compliance of procedures, quality management system records, manufacturing batch records, and associated testing.
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Be the QA representative for new products and for change projects, dealing with aspects including review/approval of process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition.
The QA officer is expected to identify, escalate, and work to address any GMP/GxP issues with potential impact to product quality or quality compliance.
As a QA Officer at Piramal Healthcare UK Limited, you will be responsible for ensuring that all products and processes meet established quality standards and regulatory requirements.
Job Responsibilities
- Perform in-process and final product inspections, ensuring adherence to Good Manufacturing Practices (GMP) and company procedures.
- Review and approve batch records, deviations, and change controls, ensuring compliance with regulatory guidelines.
- Participate in internal and external audits, including preparing audit reports and following up on corrective and preventive actions (CAPAs).
- Investigate quality issues, non-conformances, and customer complaints, identifying root causes and implementing effective solutions.
- Develop, revise, and implement Quality Management System (QMS) documentation, including Standard Operating Procedures (SOPs) and work instructions.
- Provide quality assurance support and training to other departments as required.
- Monitor environmental controls and ensure compliance with relevant regulations.
- Maintain accurate and organized quality records and documentation.
- Contribute to continuous improvement initiatives within the Quality department.
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Job Qualifications
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology, Biotechnology) or a related field.
- Proven experience (2+ years) in a Quality Assurance role within the pharmaceutical or healthcare industry.
- Strong understanding of GMP, GLP, and relevant regulatory requirements (e.g., MHRA, FDA).
- Experience with QMS documentation, including SOPs, deviations, CAPAs, and change control.
- Excellent attention to detail and strong analytical skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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