Our client, a leading global biopharmaceutical organisation with worldwide operations, offers a comprehensive portfolio of biopharma products and services. Safety and quality are among their top priorities, as well as their mission to improve the health and well-being of people around the world. They have been in operation for over 100 years, and they produce and market innovative medicines. They are seeking a QA Packaging Manager for their sterile manufacturing and secondary packaging biologics plant, reporting to the Technical Director.

The Role

Key responsibilities include:

Communication

• Daily briefing on Quality batch review/approval.

• Provide quality performance information as required.

• Ensure regular Quality interaction with other Departments and sister sites.

Quality Release Activities

• 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.

• Establish and manage a Quality Packaging Team.

• Quality Assurance program to maintain cGMP compliance in Packaging Operations area.

• In process quality checks for packaging operations.

• Other duties relevant to packaged products including but not limited to retention sample management of batch release samples, walkthrough audits.

• QA approval of visual inspection of Media Fill and product bags.

• Support product recall activities.

Other Activities

• Generation of annual product quality reviews.

• Support the change control process.

• 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.

• Annual assessment of performance for QA packaging group.

• Any other task assigned by the Technical Director.

The Person

• Minimum of 10 years relevant experience in the pharmaceutical sector.

• Languages: 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.

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

Desirable Qualifications

• QP Eligible with a university degree in Pharmacy OR university degree in a Science related discipline, together with a post graduate course which satisfies the educational requirements as defined in Directive 2001/83/EC.

• Lead Auditor Certified.

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.

To discover more about this opportunity, apply now or contact Anita Osibuamhe at HRM on +353 1 6321870 for a confidential discussion.