QA Packaging Manager
- Posted 09 May 2023
- Salary€80000.00 - €90000.00 per annum
- Job type Permanent
- DisciplineScience Leaders & Specialists
- ContactAnita Osibuamhe
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.
Key responsibilities include:
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.
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.
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.
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.