QA Compliance Expert

vor 5 Stunden

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting a QA Compliance Expert for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. The client is focused on offering novel healthcare resolutions to acknowledge the developing requirements of patients and communities.

**Responsibilities**:

- If able, handle supplier management actions such as agreements, supervision, reviews, etc.
- Guarantee all actions in compliance with cGxP which involve data integrity.
- Manage the planning/assistance and organisation of CAPA/follow-up.
- Review and plan inspection and assistance.
- You will handle modified control audits/sanctions for multifaceted alterations.
- Warrant local DI and eCompliance supervision such as training, examinations, design, risk ID, etc.
- When pertinent, you will serve as a Site reg-CMC facilitator, a Change Coordinator or a Site DI responsible.
- Responsible for QP assertion appraisal and consent.
Prepare and assist with PQR/APQR actions.
- Assist with site qualification and validation actions such as preparing, giving guidance, assessing.
- Execute Quality Systems.
- Certify process quality assurance rendering to guidelines.
- Act as a point of contact for communing with HA, GCA/One voice/united tactic/interactions for all sites in the same HA dominion/country.
- Conform to all HSE protocols.
- You will notice and document possible accidents, risks and suggest resolutions.
- Contribute to HSE risk evaluations.
- Plan and partake in internal HSE reviews.
- Accountable for contributing to initial mentoring and retraining.
- Other duties may be assigned to this role.
**Skills & Requirements**:

- Familiarity with pharmaceutical quality control, quality assurance or production.
- Must be able to work in Switzerland.
- Educated to a degree level in chemistry, pharmacy, biology, biochemistry or similar discipline with a background in science or technology.
- Fluency in the English and local language.
- Works well in a team setting, focused on outcomes.
- A resilient individual who is eager to learn more, operates well with the ability to use technology and digital mechanisms.
Know-how of GMP, Quality Assurance; Quality Standards.
- Possess technological competence; activities focused; functional professional skills; augment work processes.

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.

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