Are you ambitious and interested in working in the Quality team of a growing pharmaceutical organisation with a global presence?
Are you seeking to further your career with continued professional development?
Are you looking for a new challenge and the opportunity to work on interesting projects?
If you are answering yes, then consider our position! We have ambitious plans and have an exciting opportunity for a permanent full time Manager / Senior Manager, Quality Assurance based at our Dublin office.
This is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated products that address unmet medical needs. The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units. The company's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
This position is responsible for maintaining and managing the Quality System (PQS) including oversight of external supplier management to enable effective Quality oversight and compliance to relevant regulatory guidelines.
The individual 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.
Responsibilities? 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 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.
Qualifications and Skills Required:
- Masters degree in chemistry, biology or a related discipline is desirable.
- Experience (minimum 6-8 years) working in finished product pharmaceutical / biologics, 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 and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
The Company value and look to recruit people with the following approach to work.
Have you got the following skills?
cv to email@example.com