Job Purpose

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

Key Duties and Responsibilities

1. To be the Product Quality Owner for Theramex’s products
2. Establishing and maintaining close working relationships with the Contract Manufacturing Organisations (CMO) and internal stakeholders (Supply Chain, Regulatory Affairs, Medical, Marketing) for assigned products.
3. Support quality compliance of assigned products manufactured at Contract Manufacturers through:
• Creation and Maintenance of Quality / Technical Agreements
• 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
• Ensuring CMOs are supplied and adhere to Compliance Files / Marketing Authorisations
• Quality approval of artwork
• Assessment and approval of deviations
• Manage and approve change controls
• Investigation and resolution of complaints with CMOs
• Determining and implementing robust CAPA’s as required
• Performing in-market release of assigned products after batch certification performed by Qualified Person
• Appropriate use of risk assessments and justifications to provide pragmatic solutions
• Batch Review all MIA Products Prior to QP Certification
4. Author and approval of Standard Operating Procedures
5. International travel to suppliers / contract manufacturers

Capability Requirements (Skills, Education and Experience)

Skills

• Experience in cooperation with external CMOs from MAH side
• 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.
• Digital Savvy

Education

• A degree or equivalent in a relevant scientific subject is desirable.
• Meets the minimum requirement of Polish Pharmaceutical Law art. 48 to become a QP in the future

Experience

• Previous work in a Quality function within the pharmaceutical industry or another highly regulated industry.
• Some experience of key areas of Quality Assurance and pharmaceutical Quality Management Systems (complaints, CAPA, deviation, change control).
• Prior experience of Combination Devices (Desirable)