QA VALIDATION ()
Beschrijving:
As a member of the QA validation, the selected candidate will be responsible for:
The execution & follow-up of the IQ-OQ, PQ, validation periodic review, deviation and CAPA linked to the validation in accordance with the procedures.
Main tasks and responsibilities
You will:
- Take part in the implementation and the follow-up of the continuous validation plan (CVP),
- Define the validation strategies through the change control process (RPC),
- Write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
- Review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
- Ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
- Ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
Skills
You have:
- A strong knowledge of GMP regulated environment,
- The ability to work as part of a multidiscipline team as well as an individual,
- A good organizational skills and ability to manage their time and identify priorities,
- An analytical, logical and practical person,
- A good reactivity when facing challenges such as changes in schedule,
- A rigor in following documentation and the project stages in accordance to the requirements.
Profile
- Scientific university degree (Pharmacist, Engineer or equivalent)
- Experience in the pharmaceutical industry
- Experience in validation
- You speak and write fluently French and English
Who are we?
CVO-EUROPE, company of the CVO-CyberConseil Group founded in 1995, operates in Telecommunication, Banking & Insurance, Energies and Pharmaceutical Industries.
CVO-EUROPE offers Consulting, Assistance, Management, Assistance to Project Owner & Project Management, Audit, Recruitment and Training services and solutions. CVO-EUROPE, established in Belgium, France, Switzerland and the United States, has more than 250 co-workers.
Our offer
- An international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting projects
- A strong corporate culture insuring a personal and professional blooming and self-fulfillment
- Overall trainings and a personal career management
- A good salary package with lot of extra legal advantages
Categorie:
Geef een reactie