Supplier Auditor

Supplier Auditor (Romania)
for our production site in Romania

The Aenova Group is one of the leading companies in the pharmaceutical and healthcare industry. With high quality standards, innovative technologies, and a clear future orientation, Aenova has become Europe's market leader for the development and production of all common dosage forms and product groups in the business-to-business sector. The company which has its headquarters near Munich (Germany), operates 15 production sites and several sales offices in ten countries throughout the world. More than employees contribute to the group’s success.

What can you expect?
We are looking for a new colleague to join our team of excellence as an Supplier Auditor for our Quality Assurance Department!

Job Purpose

• Conduct GMP and Quality System audits to own sites/entities (e.g., production sites, commercial affiliates, and development entities as applicable) and Key Thirds party contractors or suppliers as Lead or supportive auditor, to monitor that all the aspects of the operational business comply with GxP and regulatory requirements and Aenova Group Quality Manual and Policies. Conduct all necessary assigned audits (from the yearly Global Audit Plan, pre-qualification, mock-pai, ad-hoc or for-cause audits) including the preparation phase and communicationcross-sites to collect all the audit info.
• Provide the finalized signed Audit Reports to the Audit Managers assigned for the respective supplier.
• Approve Corrective and Preventive Actions which are necessary due to audit findings.
• Support local auditors training sessions, audit planning and Risk Assessments (e.g., for Supplier Qualification)
• Identify and report Critical Compliance Risks and Gaps during audit activities.
• Provide effective support during Regulatory Inspections as requested by QA Operations/sites.
• Perform auditing activities required in the electronic system DHCV Audit Module. Key Performance Indicators Assigned audits are conducted in accordance with the plan, around 30 audits/calendar year, mainly EU area.
•  Reports are comprehensive, accurate and to an agreed standard, performed in timely manner (one calendar month)
• All CAPAs plans managed adequately (requested to the auditee, verified, and approved. 
• All trainings and compliance site support performed.

What should you bring?

•  University degree (or equal) in Pharmacy, Chemistry, Microbiology, Biology, Biochemistry, or another related science; additional knowledge in Quality Assurance/Compliance and Auditing.
• Experience: Minimum 5 years of experience in pharmaceutical industry, e.g., Production, QA, Quality Control, Development. Prior Auditing experience to be proven (by training and in-field expertise).
•  Languages: English fluent in speaking and writing, 2^nd language desirable
• Personal profile: Strong analytical skills, travel flexibility, very good communication, and organizational skills.
• Personal profile: Strong analytical skills, travel flexibility, very good communication, and organizational skills.

Benefits:

Here, you’ll find opportunities for professional development, ongoing training, and support to reach your full career potential. We seek individuals who share our passion for excellence and believe in the power of teamwork.

•  Competitive Salary and Growth and Development Opportunities: Ensuring financial security and long-term career opportunities.
•  Meal Tickets: You'll benefit from meal tickets valued at 40 Ron/working day, approximately 840 Ron/month.
• Daily Transport Reimbursement: We support our employees with daily round-trip transport reimbursement.
•  Generous Paid Leave: Providing 22-28 working days of annual leave, depending on your seniority, for relaxation and leisure.
• Private Medical Insurance: We understand the importance of your health, we provide access to medical care through a private health insurance.
• Bonuses: Vacation vouchers, Easter and Christmas bonuses, company anniversary and loyalty bonuses, and various other rewards for your commitment.
•  Support: Encouraging work-life balance by providing gifts for employees' children on special occasions, organizing camps for employees' children, fostering a team that grows and cares for each other.
• Inhouse and external specialized training.
•  And of course, coffee or tea to start your workday with energy and enthusiasm!