QA Operations Senior Specialist

In this role you will have an opportunity to take part in the whole life cycle of biopharmaceutical product development and production. You will be responsible for risk assessments, investigations related to deviations, proper documentation management and preparations for audits and inspections.

• Ensuring cGMP and regulatory compliance of operations leading to biological Drug Substance and Drug Product
• Supporting that all aspects of handling and manufacturing of biopharmaceutical products at our site comply with the requirements that meet all relevant cGMP regulatory and legislative requirements
• Ensuring that a high quality of products is achieved through qualification and validation based on quality risk analyses, product quality assessments, and ongoing verification
• Supporting the whole life cycle management of a manufacturing facility, up to and including GMP compliant market production
• Ensuring that all processes and products at the site meet all internal and external requirements
• Establishment, implementation and supervision of the required quality processes in product development, manufacturing, testing, storage and distribution
• Batch records’ and all related documentation review
• Participation in investigations on deviations and complaints, OOS/OOT, recalls and escalations
• Supporting change control requests, assuring GMP and regulatory compliance
• Participation in risk assessments
• Supporting all product and process related activities e.g. process transfers, process characterizations, process validations and continuous process verification (including e.g. stability studies, hold time studies, approval of protocols and reports)
• Supporting preparation of Annual Product Quality Reviews
• Preparation and review of required GMP documentation – assisting in coordination and preparation of Polpharma Biologics for inspections, audits and controls
• Participation in internal and external audits
• Support establishment of Quality Management System documentation in accordance with the requirements of Polpharma Biologics and the HA requirements in reference to diverse market areas
• Ensuring correctness and data integrity of all regulatory and manufacturing data

• University degree (Biology, Chemistry, Pharmacy, Biotechnology or related)
• 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products
• Excellent knowledge of GMP requirements and pharmaceutical laws and regulations
• Understanding of analytical technologies related to the evaluation of biopharmaceutical products, knowledge of sterile pharmaceutical production
• Understanding of issues and needs related to qualification and validation processes in biopharmaceutical manufacturing
• Knowledge of Quality Management Systems, incl. quality requirements in clinical trials and Pharmacovigilance
• Experience of Biotechnological manufacturing or commercial production
• Fluent English