Job Title: Senior Associate - Quality Assurance Specialist
About the Role:
The In-Market & Distribution Quality Senior Associate (Deputy Responsible Person) will support the Head of In Market Distribution Quality in ensuring compliance with Good Distribution Practice (GDP) requirements. This role is responsible for safeguarding product users against potential hazards arising from poor distribution practices.
Key Responsibilities:
- Safeguard product users against potential hazards arising from poor distribution practices, as set out in EU Guidelines on Good Distribution of Medicinal Products for Human Use and HPRA Good Distribution Practice of Medicinal Products for Human Use as amended.
- Meet the requirements of an RP in accordance with EU regulations and HPRA GDP Guidance Documents as amended.
- Ensure compliance with BioMarin Wholesale Distribution Authorisation (WDA) and relevant Good Distribution Practice (GDP) guidelines.
- Implement and maintain a Quality Management System, including quality risk management, corrective and preventative actions, change control, measurement of performance indicators, and management review.
- Manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.
- Ensure initial and continuous training programs are implemented and maintained.
- Coordinate and promptly perform any recall operations for medicinal products.
- Cooperate with marketing authorization holders and national competent authorities in the event of recalls.
- Ensure relevant customer complaints are dealt with effectively.
- Carry out due diligence checks and ensure that suppliers and customers are qualified and approved.
- Approve any subcontracted activities which may impact on GDP.
- Perform self-inspections at appropriate regular intervals following a prearranged program and put necessary corrective measures in place.
- Decide on the final disposition of returned, rejected, recalled or falsified products.
- Assess and approve any returns to saleable stock.
- Adhere to the requirements of the Falsified Medicines Directive 2011/62/EU, ensuring adequately robust procedures are in place.
- Understand the requirements of serialization.
- Ensure supply chain security policies and procedures are in place and adhered to.
- Demonstrate the application of activities and provisions in accordance with the BioMarin WDA and company processes and procedures.
- Ensure the accuracy and quality of GDP records and that relevant procedures are maintained through good documentation practices.
- Develop GDP business processes, procedures, and best practices.
- Measure performance indicators and ensure management review of these performance indicators.
- Ensure that any additional requirements imposed on certain products by national law are adhered to.
- Maintain current regulatory knowledge by regularly using regulatory websites as applicable to read any changes to guidelines and regulations.
Requirements:
- Strong understanding of Good Distribution Practice (GDP) regulations and guidelines.
- Ability to implement and maintain a Quality Management System.
- Experience in managing authorized activities to ensure compliance with GDP.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Proficiency in Microsoft Office applications.
Benefits:
This role offers a competitive salary and benefits package, including opportunities for professional growth and development.
How to Apply:
If you are a motivated and detail-oriented individual with a strong understanding of Good Distribution Practice (GDP) regulations and guidelines, please submit your application for this exciting opportunity.