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Pharmacist production environment

Hamont Achel
Fixed
39 hours per week
Project Management
63112
Reference: 63112
Date: 2024-02-15
Sharon Sannen
Recruitment Partner
014/337 567
014/337 567
sharon.sannen@ctrl-f.be
Technical Engineering Lommel
lommel@ctrl-f.be
Vreyshorring 49, 3920 Lommel
69107
18152
https://wa.me/32477711688
  • Permanent contract of unlimited duration.
  • A versatile and challenging job in a strongly growing company, in which you actively participate in the further development of the organisation.
  • Working in a traffic-free environment.
  • A competitive salary package, supplemented by numerous additional benefits including meal vouchers, hospitalisation and invalidity insurance and group insurance.
  • A full-time job with flexible working hours and an interesting leave scheme (20 leave days + 11.5 recovery days + 2 sector days).


Questions or interest?

>> lommel@ctrl-f.be

>> 014 33 75 67 

>> WhatsApp: 0477 71 16 88

Function

Act as delegated responsible pharmacist (QP) to ensure that each batch is produced and controlled in accordance with the laws and requirements of the market authorisation.

- Act as delegated QP by performing batch decision and then registering the batch in the batch release register in line with Annex 16 of the EU Good Manufacturing Practice Guideline entitled: Certification by a qualified person and batch release, and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.

- Supervise the quality system to carry out batch release tasks in accordance with Annex 16 of the EU Good Manufacturing Practice Guideline entitled: Certification by a qualified person and batch release, and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.

- Review and approve changes proposed through the change management system.

- Review and approve final investigation reports on incidents, complaints and investigations.

- Participate in quality system improvement to ensure appropriate cGMP level.

- Participate in activities to improve cGMP.

- Ensuring timely and appropriate batch decision decisions.

- Participate in projects and contribute to: project execution, validation activities and strategy, compliance with existing legislation or customer requirements and proper implementation of the project in the production environment.

- Provide training to other staff by demonstration, repetition, modelling, large-group training, etc.

- Assist in monitoring the proper operation of the quality management system. Monitor the quality system, review and approve change requests, CAPA plans and quality assessment results.

- Timely APR / PQR writing.

-(Delegated) Responsible pharmacist, acting under the: Royal Decree of 6 June 1960, Directive 2003/94/EC; 91/412/EC, Directive 2001/83/EC; 2001/82/EC

- Integrity of batch documentation, through review of batch records, review of analytical data and other relevant batch information.

- Key (supporting) role in customer and authority audits.

- Act as lead auditor during supplier audits.

Organisation

The company is part of a group and is responsible for the packaging and labelling of medicines. 

Profile


- You have a master's degree in pharmacy.

- Accreditation as QP, in accordance with: Royal Decree of 6 June 1960, Directive 2003/94/EC; 91/412/EC, Directive 2001/83/EC; 2001/82/EC

- Supplemented by relevant training and courses.

- Initial experience in a pharmaceutical manufacturing QP role.

- Active and in-depth knowledge of international cGMP guidelines and pharmaceutical regulations.

- Knowledge of medical device regulations.

- Team player, able to work with all levels of the organisation.

- High level of integrity.

- Thinks in processes.

- Positive mindset / Thinks in solutions.

- Decisive.

- Accurate.

- Organised work processes / sets priorities.

Apply for this vacancy.

We will get back to you as soon as possible.

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