Cqv Lead

Vor 2 Tagen


Stein, Schweiz Proclinical Vollzeit

Proclinical are recruiting a CQV Lead for a pharmaceutical organisation. This role is on a contract basis and is located in Stein. The client is focused on facilitating a healthier community.

**Responsibilities**:

- Guide the allocated team of drug product (DP) ancillary and lab equipment.
- Assist in / contribute to validation actions throughout facility start-up.
- Offer guidance of CQV actions within allocated project(s) in Switzerland.
- Network with site operation/site QA/SGIE-Quality.
- Maintain oversight on the company's CQV standards, deadlines, etc.
- Handle QV-Documents such as Suppliers / QV-Team /QA.
- Acknowledge immediate time/quality constraints and act adequately.
- Manage commissioning reports such as for suppliers, process engineers, EMR, etc.
- Other duties may be assigned to this role.

**Skills & Requirements**:

- Educated to a degree level in an engineering or applied science discipline.
- At least 12 years of experience in commissioning, qualification and validation which involves CSV.
- Familiarity with handling multifaceted pharmaceutical projects, biologics, as well as chemical manufacturing technologies.
- Acquaintance with qualification of aseptic filling lines and affiliated equipment, for example: vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators.
- Prior involvement in regulated pharmaceutical and/or engineering organisation with demonstrated experience on planning CQV actions, guiding large senior documents and high comprehension/management KPIs.
- Fluency in the English language with knowledge in German would be advantageous.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-SH1

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