Quality Specialist – Product Compliance
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Job Location:
Monthly Salary:
Posted on:
29-10-2025
Vacancies:
1 Vacancy
Job Summary
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 Theramexs 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 CMOs 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
- A degree or equivalent in a relevant scientific subject is desirable
- Has prior experience of Combination Devices (Desirable)
Key Skills
- Sales Experience
- Marketing
- Customer Service
- Communication skills
- Military Experience
- Retail Sales
- Product Demos
- Customer Support
- Product Management
- Product Development
- Unity
- Microscopy
About Company
We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.Wework closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the ti ... View more
