interim Senior GMP Specialist

Werkgever CheckMark Labrecruitment
Plaats Regio Leiden
Provincie Zuid-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum donderdag 28 december 2017
Sluitingsdatum donderdag 25 januari 2018

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Functieomschrijving

As a Senior GMP Specialist you make sure that the GMP Quality processes adhere to the applicable GMP regulations

As a Senior GMP Spcialist you make sure that the GMP Quality processes adhere to the applicable GMP regulations (e.g. Eudralex, FDA, ICH).


- You make sure the GMP Quality Processes are consistent within the organization through internal audits, gap assessments, and risk assessments.
- You are a key contact for GMP Compliance and/or training topics within Janssen Biologics and internationally (associated companies, Headquarters, Regulatory Agencies).
- You provide GMP advice to improvement projects and you have an active role in the implementation of such projects.
- You organize and support Health Authority inspections, 3rd party inspections, and Headquarters audits.

Profiel

Opleiding WO
Ervaring Ervaren (3 - 8 jaar)
For the position of Senior GMP Specialist we are looking for a candidate with a Master degree (biosciences) with a minimum of 6 years of relevant work experience in Quality/Compliance


- Knowledge of GMP regulations and preferably knowledge of automated systems and/or validation.
- Proven leadership skills in a professional environment.
- Able to translate complex situations to simple, practical solutions.
- Able to influence people without formal authority.
- Keen to recognize opportunities for improvement in and outside the department.
- Preferably experience with Lean tools.

Aanvullende informatie

- Secondment via CheckMark Labrecruitment until August 2018

- Fulltime position, but 32 hours/week is possible

Contact

Neem voor meer informatie contact op met Na Rae de Jong: 0182 590 216
Vacaturenummer: 5595

Bedrijfsprofiel

Pharmaceutical company. The department is responsible for (the improvement of) the compliance status within the company. The main focus areas are: Inspection readiness, Internal auditing, GMP (Good Manufacturing Practices) training, Management review, CAPA management, Quality metrics, and Compliance gap assessments. We work closely together with the GMP departments and associated companies worldwide.
The department consists of 8 employees, of which 5 (Sr) GMP Specialists.

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