Company:
A leading organisation in the pharmaceutical manufacturing sector committed to maintaining the highest standards of quality and compliance. The company values teamwork, precision, and a proactive approach to continuous improvement.
Job Description:
We are seeking an experienced Senior Quality Assurance Specialist to join the production team. This role is vital in supporting GMP compliance during manufacturing operations and ensuring the quality and integrity of batches produced at our Breda facility.
Responsibilities:
• Provide guidance and support on QA matters within the production environment.
• Review batch records for assembled, packaged, and labeled products.
• Establish and maintain effective relationships with Production, Warehouse, Maintenance, Engineering, and QA Management.
• Offer daily advice to production staff regarding adherence to SOPs and work instructions.
• Act as the first point of contact for quality-related production queries during packaging and labeling.
• Review and approve production batch records prior to production activities.
• Perform checks on finished products during commercial production runs.
• Prepare batch records for disposition by the Qualified Person (QP).
• Conduct GMP compliance checks throughout production processes.
• Review and approve deviation reports, ensuring proper handling and documentation.
• Lead investigations and own quality deviations as necessary.
• Assist in developing, reviewing, and updating operational SOPs and Work Instructions.
• Participate in GMP training initiatives for QA and production teams.
• Support improvement projects and various investigations within the department.
• Prepare weekly and monthly QA performance metrics and maintain departmental performance dashboards.
Requirements:
• MBO or Bachelor’s degree in Pharmaceutical, Life Sciences, or a related field.
• At least 3 years of experience in QA or manufacturing within the pharmaceutical or medical device industry, including batch record review and investigations.
• Solid knowledge of GMP, GDP, and GCP regulations.
• Experience with production and quality processes.
• Fluent in English.
Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58238
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Manideep Rachakonda
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