Quality Manager

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

Quality Manager

Responsible person according international and local laws for maintaining a Quality System based on applicable Good Distribution Practices principles and Corporate Quality standards of medicinal products and medical devices.

Activities And Responsibilities

• Be the Responsible Person as per GDP requirements.
• Assure distribution activities (procurement, storage, complaints management…) are in compliance with Good Distribution Practices regulation.
• Elaborate, approve and keep updated relevant SOPs and records.
• Responsible for the local batch release of medicinal products and medical devices in compliance with and local requirements.
• Responsible to approve returns to saleable stock.
• Overview of GDP subcontracted activities and service providers (initial and regular requalification, audits, CAPA follow up, quality agreements, performance, etc…)
• Review publicity messages and promotional material from a Regulatory perspective.
• Responsible and local contact for pharmacovigilance.
• Obtain and keep updated all the licenses necessary for products and/or distribution activities.
• Regulatory Affairs local contact person with local authorities and Headquarters.
• Implementation, maintenance and continuous improvement of a quality system according to GDP regulations and Corporate Quality standards: record and coordination of complaints, deviations, CAPAs, change control, risk analysis, internal and external audits.
• Host Authorities Health inspections and internal, corporate or customer audits.
• Liaison with National Regulatory Authority of the country and neighboring countries.
• Liaising with other parties including with Quality personnel at manufacturing sites, Logistics and Customer Services, headquarters, etc.
• Ensure training programmes are implemented, maintained, and effective for all relevant staff.
• Lead and coordinate recall operations.
• Other applicable by local laws.

Academic Requirements

Degree in Pharmacy.

Knowledge Skills And Abilities

• Strong resourcefulness and ability to proactively seek information, engage with stakeholders and independently resolve issues.
• Excellent organizational skills.
• Excellent attention to detail.
• Team Player and strong interpersonal skills.

Professional Experience

• 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.

Scope

Countries associated to the affiliate (Poland and other Baltic countries).

IT

• Proficient in Microsoft Office (especially Excel and Word).
• SAP user level.

Languages

• Local language
• ENGLISH: advanced level.

Location

EMEA : Poland : Warsaw:Polska