Our speciality pharmaceutical client have a large portfolio of products across pharmaceuticals, biologics and medical devices. They are seeking an experienced Quality Specialist to join the Quality team at their Global HQ in South Dublin. This is initially a 6-month contract, with remote working options available.
Duties and responsibilities of the Quality Specialist will include but are not limited to:
- Responds to and escalates events identified as nonconformance
- Performs periodic review of quality documents and updates as necessary
- Understands and stays current with regulatory guidance
- Supports site inspections/audits by providing requested documentation, acting as SME for primary job functions, and acting as scribe as needed
- Creating GMP documents according to approved templates/procedures and managing the change control approval cycle
- Review and approve GMP documents received from contractors e.g. master batch records, analytical test methods, protocols etc.
- Manages issuance of required distribution copies of documents (internal and external) ensuring retrieval/destruction at obsolescence
- Perform a quality review on batch documentation received from contract manufacturing / packaging sites.
- Monitor / liaise with Quality at contractors to ensure timely receipt of batch documentation and resolution of quality issues.
- Receives & logs complaints; gathers information from call centre and complainant; generates acknowledgement letter and sends to complainant
- Assesses and evaluates the criticality of complaints, escalating those that may be a FAR
- Provides notification of complaints and status to key stakeholders
- Assists and/or performs investigation of the complaint
You will have skills and experience in the following to be considered:
- BSc and 3+ years relevant industry experience
- Experience working in a Quality Compliance function preferred
- Understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
- Knowledge of US and EU Regulations (ICH, EU GMPs, US CFRs, ISO, etc.)
- Knowledge of electronic data systems
- Able to communicate effectively with other departments, management and operational personnel
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
- Detail oriented, able to work independently and work well in a team environment
- Excellent proof-reading skills; ability to identify errors
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.