Quality Assurance Manager

Quality Assurance Packaging Manager

Reporting directly to the Technical Director of Grifols Worldwide Operations (GWWO), the QA Packaging Manager will be responsible for a range of GMP and product release support for secondary packaging activities including quality activities for Media Fill and product visual inspection, 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.

Applicants will possess a minimum of a Chemistry, Biology, Engineering or equivalent third level degree qualification , with minimum 10 years' experience in Pharma Quality Assurance

Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.

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.

RESPONSIBILITIES

1 Communication:

1.1 Daily briefing on Quality batch review/approval

1.2 Provide quality performance information as required

1.3 Ensure regular Quality interaction with other Departments and the Grifols sister sites

2 Quality Release Activities:

2.1 Support Product release process (packaging step)

2.2 Support quality Visual inspection activities for media fill and product batches

2.3 Establish and manage QA Packaging Team

2.4 Develop Quality Assurance program to maintain cGMP compliance including deviations and CAPA management

2.5 Oversight of In process quality checks for packaging operations

2.6 Support Product release of packaged product

2.7 Support product recall activities

Other activities:

3.1 Generation of annual product quality reviews

3.2 Support the process change control system

3.3 Support deviations and products complaints investigations

3.4 Support the quality audit/inspection programmes

3.5 Process/product/system improvement projects

3.6 Drive and oversee process and products

3.7 Training of new Quality personnel

3.8 Review and Approval of Batch records and SOPs

3.9 GMP implementation and site-wide Quality Awareness.

3.10 Facilitate Inspections by third parties, e.g. HPRA, FDA,

customers, etc.

3.11 Responsible for follow up corrective actions identified through

the Deviation system.

3.12 Liaise with other Department representatives to promote

improvements in GMP and Quality standards.

3.13 Keep abreast of the latest developments from regulatory

authorities in relation to Quality Compliance activities.

3.14 Participating in the Self inspection program

3.15 Any other task assigned by the Technical Director

REQUIREMENTS

• Minimum of 10 years relevant experience in the pharmaceutical sector
• Previous experience in managing
• Very good English (written and oral)
• Excellent verbal and written communications
• 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 an advantage