Quality Specialist – Product Compliance

• Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
• Batch Review all MIA Products Prior to QP Certification
• Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
• Investigation and resolution of complaints with CMOs
• Determining and implementing robust CAPAs as required
• Assessment and approval of deviations
• Managing and approval of change controls
• Creation and Maintenance of Quality / Technical Agreements
• Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
• Support of on-site audits and visits
• Ensuring product quality reviews and stability studies are completed and assessed
• Ensuring products comply with applicable regulations, general and product monographs of applicable pharmacopeias
• Quality approval of artwork
• Performing in-market release of assigned products
• Appropriate use of risk assessments and justifications to provide pragmatic solutions

• Experience working in Quality Function within the Pharmaceutical industry
• Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
• Basic Knowledge of the Pharmaceutical GxP regulations
• Able to foster strong cross-functional relationships
• Influence, interpersonal, verbal, and written communication skills
• Able to respond positively to, and effectively implement, change
• Digitally Savvy
• Fluency in both English and Polish to handle communication with healthcare authorities in Poland
• A degree or equivalent in a relevant scientific subject is desirable

Has prior experience of Combination Devices (Desirable)