GDP Quality Manager — Medicines & Devices

Grifols; Warszawa; On-site; PLN 80,000 - 100,000; Full time

Job summary

Grifols in Warsaw is looking for a Quality Manager responsible for maintaining a Quality System compliant with Good Distribution Practices and Corporate Quality standards. The role requires overseeing distribution activities and ensuring compliance with local regulations.

A degree in Pharmacy is essential, along with at least 5 years of experience managing Quality Systems. The successful candidate will liaise with regulatory bodies and oversee audits and inspections.

Qualifications

• 5 years’ experience managing a Quality System in a similar position.
• Experience in GDP.
• In-depth knowledge of Polish and EU legislation applicable to medicinal products and medical devices.
• Regulatory Affairs experience preferred.

Responsibilities

• Be the Responsible Person per GDP requirements.
• Ensure distribution activities comply with Good Distribution Practices.
• Elaborate, approve and update relevant SOPs and records.
• Manage local batch release of medicinal products and medical devices.
• Approve returns to saleable stock.
• Oversee GDP subcontracted activities and service providers.
• Review publicity messages from a Regulatory perspective.
• Contact for pharmacovigilance.
• Obtain and maintain necessary licenses.
• Implement and improve quality system according to GDP regulations.
• Host Authority Health inspections and audits.
• Liaise with National Regulatory Authority.
• Ensure effective training programmes.
• Lead recall operations.
• Other applicable by local laws.

Skills

Strong resourcefulness

Excellent organizational skills

Excellent attention to detail

Team Player and strong interpersonal skills

Education

Degree in Pharmacy

Tools

Microsoft Office (Excel, Word)

SAP user level

Job description

Grifols in Warsaw is looking for a Quality Manager responsible for maintaining a Quality System compliant with Good Distribution Practices and Corporate Quality standards. The role requires overseeing distribution activities and ensuring compliance with local regulations.

A degree in Pharmacy is essential, along with at least 5 years of experience managing Quality Systems. The successful candidate will liaise with regulatory bodies and oversee audits and inspections.