Quality Assurance Associate Director
Over the past five years our client has enjoyed double digit global growth though a judicious strategy of acquisitions and sales growth. This highly regarded pharmaceutical company is now looking to hire a number of bright, action-oriented self-starters to take on the challenge of delivering on its highly ambitious future plans.
This newly created position will be responsible for maintaining and managing the Pharmaceutical Quality System (PQS) including oversight of external supplier management to enable effective Quality oversight and compliance to relevant regulatory guidelines. The successful appointee will be responsible for performing key quality tasks with respect to commercial products and development/clinical projects specifically in the areas of document control, coordination of training.
- QA oversight of operational activities, ensuring alignment and adherence to quality agreements and procedural requirements for product(s) within the assigned Business Unit.
- QA oversight for all batch release, for product(s) within the assigned Business Unit.
- Continuing development, implementation and maintenance of the Pharmaceutical Quality System and supplier management program.
- Management of complaints, deviations, CAPA’s and change control notifications associated with commercial products.
- Operation and maintenance of quality documentation system.
- Preparation and delivery of training on Quality related systems, procedures and processes.
- Developing, preparing and compilation of quality metrics for monthly report.
- Coordinating and leading periodic review of the PQS and management review.
- Participating in the preparation of annual reports, annual product reviews and core documents.
- Supporting supplier qualification, external audit and internal quality review.
- Investigating out-of-trend/specification (OOT/S) reports.
- Conducting internal audits and/or co-ordinating the self-inspection program.
- Supporting regulatory submissions.
- Review and approval of product artwork.
- Supporting development projects.
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Maintain up to date Quality Technical Agreements with all GxP vendors and take on other activities/responsibilities as required due business needs.
- Bachelor’s degree in chemistry, biology or a related discipline is desirable.
- Experience working in finished product pharmaceutical / biologics, ideally including working in a virtual organisation.
- Strong technical expertise including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
- Experience with third party vendor auditing, out of spec investigations, change control.
- Thorough understanding of quality systems and GMPs.
- Experience working with contract manufacturing sites or virtual manufacturing.
- Experience interfacing with regulatory bodies or working on regulatory submissions is desirable.
- This role requires good judgment, strong initiative and the ability to drive for results.
- In a rapid growing, fast changing environment, you need to have the ability to deal with ambiguity, effectively prioritise and manage a diversified workload, often to strict deadlines.
- Built on a foundation of excellent technical expertise, you should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
Cv to Gerry@rftgroup.ie