Ireland Job Openings

Merck Group

Quality Assurance Associate

Dublin

FULL TIME & PART TIME

December 2, 2024

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role
The Quality Associate will manage all quality and compliance related aspects for Republic of Ireland with regards to GMP and GDP in alignment with the strategy defined with the business and global quality functions.
Duties

Implementing a Quality Management System (QMS)
Build quality awareness within local management team and ensure that local management fulfils its role regarding quality requirements as defined in the applicable regulations.
Reporting quality performance indicators to local management and take leadership in the performance of Tier 1 Quality Councils and Quality Management Reviews.
Establishing and managing an appropriate Quality Department that covers all GMP/GDP quality critical tasks.
Implementing Corporate and Global company standards and procedures, international and local applicable GDP regulations
Ensure that the defined quality systems and standards are implemented and followed so that the high-quality standards of the company are achieved.
Perform Product Disposition for all shipments received in country.
Manage quality related aspects of company GMP/GDP vendors and partners in the country.
Liaise with quality global functions (HCQ) and report status of quality systems implementation, KPI and quality issue
Local QA activities and quality systems in place, and maintained
Release for Sale at Subsidiaries, if applicable: verification of relevant documents to confirm compliance of products received and on time local release for sale to market
Product Launch: participation in product launch activities as per relevant global procedure and needs of local subsidiary including, if applicable, forecasting and management of reference standards, reagents etc. if needed for initial / ongoing HA testing requirements.
Product Returns: assessment of product returns and supporting information to verify if products are suitable for return to saleable status or destruction.
Management of quality activities impacted by FMD implementation for EU Subsidiaries (as applicable)
Training of local personnel on locally implemented quality systems and GMP/GDP matters (training program, training record)
Coordinating product recalls and withdrawal at the local level including investigational medicinal product (IMP) and marketed medicinal products
Handling of GMP/GDP deviations (including receiving, recording, investigating and closing out)
Oversee Change Control management for GMP/GDP activities including the implementation of an appropriate action plan
Handling and escalation of complaints received from customers (including receiving, recording, investigating and closing out)
Implementation and management of quality documents including review and approval of quality documents
Create internal and external audit plan, program and audit execution by qualified auditors. Manage Health Authority inspections, as part of the audit plan.
Maintain a positive relationship with local health authorities in partnership with local Regulatory Affairs
Ensure GMP/GDP critical vendors are qualified (maintaining a master vendor list, establishing Technical Agreements with the vendors, assuring vendors are regularly monitored / followed up)
Ensure corrective and preventive actions are defined in a timely manner, documented, tracked and closed in order to improve continuously the quality of the quality processes
Act as the local coordinator for Product Alert activities as required
To recognise a reportable Adverse Event (AE) or Safety Information and ensure the information is forwarded to the Local Patient Safety Person (LPS) within 24 hours
Ensure the Adverse Event / Product Complaint reconciliation process is established and maintained.
Implement a quality risk management process on the QMS processes
Act as a local Quality Learning Coordinator (as applicable)

Who You Are

Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field
Background in Medicinal product distribution highly desirable
2 to 3 years' experience related to Pharmaceutical or other related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management or other related activities
Experience in Good Distribution Practices
Knowledge in local laws and local regulations applicable to the operation
Proven experience in the area of GMP/GDP and/or quality assurance systems
Willingness and enthusiasm to share knowledge
Good time and priority management skills
Ability to prioritize and work in a rapidly changing environment.
Excellent negotiation and influencing skills, highly desired but not essential
Ability to travel nationally and internationally
Computer skills (Word, Excel, Share Point, etc.)
Basic Project Management and related tools skills, highly desired but not essential

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

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