Global Lead Auditing

il y a 2 semaines

Brussels, Belgique Plasma Industries Belgium Temps plein

**Function**: Global Lead Auditing

Reporting to the Global Senior Manager QA Systems

**Purpose**:
As the Global Lead Auditing being the first point of contact, for all supplier related audits and internal audits. Ensuring timely and adequate handling of audit/inspections, observations, and the provision of management reports in this regard. Consider policy and laws and regulations regarding the quality system within the Prothya organization. Identifies deviations in the quality and uniformity of completed audits and proactively realizes improvements in the entire audit process.

**Accountabilities**:

- Ensures that internal and external audits are adequately designed, carried out and managed, ensuring sufficient support for fellow auditors and SMEs. Is therefore involved in the execution of audits both independently and coordinatingly.
- Ensure sufficient auditors are trained and qualified withing Prothya.
- 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, identifies bottlenecks with internal and external stakeholders and monitors the follow-up of measures to be taken.
- Translates annual departmental business objectives to the audit program.
- Ensures collaboration within the group of internal and external auditors.
- Has a broad and in-depth understanding of existing and emerging regulatory GxP requirements within own field of expertise. Decision maker with regards to GxP (e.g. decisions on batch dispositions). Manages or gives advice on SOPs, GxP deviations and change control and follows mandatory GxP training and maintains an appropriate training record.
- Has understanding of existing regulatory GxP requirements (within area of own expertise). Interacts cross functionally to ensure GxP compliance and writes SOPs. Follows mandatory GxP training and maintains an appropriate training record. Writes GxP documentation such as deviations and change control records.
- Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
- Takes GxP requirements into account during activities. Follows mandatory GxP training. Identifies and escalates GxP issues.

**Education, experience & skills**:

- Bachelor’s degree in chemistry, Biology, Pharmacy or related
- Several years of experience in cGMP environment
- Certification as auditor
- Knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems is required.
- Experience in training of internal / external auditors

**Our Company**

Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.

**We offer**

Prothya Biosolutions BE 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. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.

We also offer an attractive holiday system exceeding the legal holidays.

Furthermore, we value mutual respect and diversity is our strength.

For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.

**Are you interested?** Send your CV and covering letter.

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