QA Packaging Manager

QA Packaging Manager

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Reporting directly to the Quality Assurance (QA) 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 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.

What your responsibilities will be

• 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
• Quality Release Activities
• Documentation review to support batch release of packaged products
• Manage a Quality Packaging Team
• Maintain cGMP compliance in Packaging Operations area
• Manage In process quality checks for packaging operations
• Other duties relevant to packaged products including but not limited to retention sample management, management of batch release samples, walkthrough audits.
• QA approval of visual inspection of Media Fill and Albumin 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

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 10 years relevant experience in the pharmaceutical sector
• Excellent Spoken and Written English
• 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

What we offer

• It's a brilliant opportunity for someone with the right talents.
• Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications.
• We'll help you grow professionally.

Information about Grifols is available at www.grifols.com. If you're interested in joining our company and you have what it takes, then don't hesitate to apply.

We look forward to receiving your application.

Grifols is an equal opportunity employer.

• Onsite position 40 hours per week
• Benefits package offered
• Permanent position