QA-s External Oversight Auditor
Il y a 7 mois
**QA-S External Oversight Auditor - Joblevel 10**
A QA-S External Oversight Auditor will perform Quality Assurance (QA) tasks regarding External oversight, ensuring quality of suppliers or service providers. Leading, executing and reporting of external and internal audits related to GMP. A QA person plays a crucial role in ensuring compliance with regulatory requirements and quality standards in the field of GMP.
**Key Responsibilities**:
- Quality Assurance activities:
- monitors compliance with policies and laws and regulations regarding the quality system within the organization in the field of Quality Oversight of suppliers and customers.
- acts as a QA point of contact for internal and external stakeholders (including suppliers and customers) with regard to quality-related aspects for suppliers in the portfolio and external customers;
- ensures quality contract management for external contacts (including suppliers and customers), manages complaints to suppliers and carries out initial assessment, (re)qualification and performance measurement of suppliers;
- ensures timely and adequate handling of audit/inspection observations and the provision of management reporting in this regard;
- assesses (strategic) documents, procedures and instructions regarding the quality system, identifies deviations and ensures their improvement.
- Promoting Quality and Advice:
- keeps knowledge up to date in the field of External Oversight
- identifies internal and external developments, opportunities and bottlenecks in the field of External Oversight and discusses this with the manager;
- represents, from External Oversight, QA in committees and working groups.
- Setting up, leading, facilitating and conducting audits:
- determines, on the basis of (changes in) legislation/regulations, internal and external requirements and/or deviations in the processes/systems, which audits must be carried out within Prothya;
- leads and carries out internal audits within Prothya;
- leads and carries out external audits at home and abroad for the qualification of external parties (including but not limited to suppliers of raw materials and services, blood collection centers, etc.);
- coordinates the work of fellow auditors and SMEs during the audit and provides instructions where necessary;
- is responsible for leading and/or preparing and facilitating audits by external parties at Prothya (including collecting documentation, monitoring follow-up of previous audits, providing pre-requested documentation and compiling and setting up the front and back office).
- Securing Audit Results:
- processes audit results in a report for the auditee, containing identified bottlenecks, risks and recommendations on measures to be taken;
- assesses the auditee’s action plan for completeness, timeliness, accuracy and alignment with Prothya’s QMS;
- monitors the follow-up of measures to be taken, identifies and discusses bottlenecks with internal and external stakeholders;
- participates in working groups and committees and advises on bottlenecks and risks from internal and external audits.
- Communication and Collaboration:
- collaborate with cross-functional teams, including regulatory affairs, Procurement and quality assurance, to ensure alignment on quality objectives and initiatives.
- communicate regularly with stakeholders to provide updates on quality activities, findings, and recommendations.
**Education, experience and skills**
- Knowledge at HBO level is required, supplemented with several years of relevant work experience in a cGMP environment.
- In addition, certification as a LEAD Auditor is required.
- Knowledge of audit methods and techniques, pharmaceutical legislation and regulations and quality systems is required
- 5 years of experience in a comparable function
- Experience in the pharmaceutical sector and in a GMP environment is a benefit.
- Independence
- Risks, responsibilities and influence
- Expressiveness
- Perseverance and patience
- Alertness
**O**ur Company**
- Prothya Biosolutions makes life-saving plasma medicines and is proud of that Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn
**We offer**
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components.
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