Job Purpose

Undertaken batch review for a variety of Products in Poland that require QP batch certification under the MIA. To ensure that products sold by Theramex are manufactured, packaged, tested, and released efficiently and in compliance with applicable quality and regulatory standards.

Key Duties and Responsibilities

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP.

Will be the Product Quality Owner for Theramex’s products which involves the need to:

• 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
• Responsibility for the support of quality compliance of assigned products manufactured at Contract Manufacturers through:
• 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

The role will require some international travel to suppliers / contract manufacturers.

Minimum Requirements (Experience & Education)

• 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 as well
• A degree or equivalent in a relevant scientific subject is desirable
• Has prior experience of Combination Devices (Desirable)