Reporting directly to the Technical Director of Grifols Worldwide Operations (GWWO). The successful candidate will be responsible for a range of GMP and product release for secondary packaging activities which can include Quality batch documentation review and control, review and approval of controlled documents including batch records and SOPs, quality performance reporting, and support of investigations, complaints and projects.
Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
The successful candidate will be responsible for the QA oversight of Visual inspections of Media fill and Albumin product bags.
The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills capable to deliver to tight and often multiple deadlines in a dynamic, challenging work environment.
- Daily briefing on Quality batch review/approval
- Provide quality performance information as required
- Ensure regular Quality interaction with other Departments and the Grifols sister sites
- Product release (packaging step)
Establish and manage a Quality Team able to perform the following duties:
- Quality Assurance program to maintain cGMP compliance including deviations, change controls and CAPA management
- In process quality checks for packaging operations
- Product release of packaged product
- QA approval of visual inspection of Media Fill and Albumin product bags
- Support product recall activities
- Generation of annual product quality reviews
- Support the process change control system
- Support the quality audit/inspection programmes
- Process/product/system improvement projects
- Drive and oversee process/product deviations investigations
- Training of new Quality personnel
- Review and Approval of Batch records and SOPs
- GMP implementation and site-wide Quality Awareness.
- Facilitate Inspections by third parties, e.g. HPRA, FDA, customers, etc.
- Responsible for follow up corrective actions identified through the Deviation system.
- Liaise with other Department representatives to promote improvements in GMP and Quality standards.
- Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.
- Participating in the Self inspection program
- Any other task assigned by the Technical Director
- Minimum of 10 years relevant experience in the pharmaceutical sector
- MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status
- QP on-licence experience of minimum 2 years
- Very good English (written and oral)
- Excellent verbal and written communication
- Strong interpersonal skills to interact with all levels of personnel in a professional manner
- Have a strong quality and compliance background in the pharmaceutical industry
- Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates
- Strong decision- making skills
- Ability to manage multiple projects simultaneously, meet deadlines
- Lead Auditor Certified Desirable
- Experience in sterile manufacturing Desirable
- Knowledge in microbiology Desirable