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Opis stanowiska pracy

Lead Auditor (Pharma)
Warszawa
NR REF.: 1192886

One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals that would contribute to its success by joining the new team.
Job Summary: We are seeking a highly skilled and experienced Lead Auditor to join our team. In this position, you will take the role as Lead Auditor in our dedicated team of auditors and highly skilled Quality Professional ensuring compliance of our portfolio of Pharmaceutical Contract Manufactures by auditing against the EU GMP EudraLex Volume 4 and GDP regulations. Furthermore, as a team member, you will have the responsibility to participate in the due diligence process associated with supplier evaluation and approval. You will also support our Quality Operations and Product Quality organizations in relation information obtained through the audit activities. 

Office location: WarsawHybrid working: 3 days office-based, 2 days home office 

Main responsibilities:

• Prepare, perform and follow-up on audits of Pharmaceutical Contract Manufactures, Laboratories, Packaging Manufactures, Warehouses, and API Manufacturers. 
• Assessment and approval of quality and audit documentation from Contract Manufacturers, Laboratories, and API manufactures. 
• Take part in assessing and follow-up on our supplier quality oversight to maintain supplier approval status 
• Take part in ongoing improvements of processes and procedures in the Pharmaceutical Quality Management System with the team and cross-functional working groups. 
• Collaborate with QA/QP when relevant in relation to audits and information sharing. 

Key requirements:

• Educational background: Master’s degree in Pharmacy, Chemical Engineering, Chemist, Biochemist or similar. 
• Solid experience and knowledge from auditing in the Pharmaceutical industry towards the EU GMP Eudralex Vol. 4 and GDP. 
• Experience within audit and supplier management processes and in supporting audits/authority inspections 
• Professional proficiency in English, which allows you to ensure great communication with suppliers and auditees, and colleagues
• Positive approach to meet challenges and changes
• Strong analytical skills 
• Collaborative team player
• Clear understanding of different cultures
• Pronounced situational awareness
• Robust, persistent, and vigorous in the audit situation
• Oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance 

What you39ll get in return

• Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
• Work in a hybrid model (3 days in the office per week)
• Potential for a permanent contract after an initial 3-month period.
• Comprehensive medical coverage through Medicover.
• Sports Card: Access to various sports facilities and activities.
• Life insurance coverage for added security.
• Opportunity to be involved in the transition of processes.
• Attractive and competitive salary.

Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.

Praca Warszawa

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