QA Commercial

Vor 3 Tagen

Bern, Schweiz Techfirm Industrial Services Vollzeit

For our _**Techfirm Industrial Services**_ team, we would like to integrate a

**QA commercial (M/W/D)**

ready to join us in Switzerland to take up new challenges together

**WHAT WILL BE YOUR TASKS**
- Offer immediate support to operations and quality control teams to address any compliance-related issues (on-the-floor QA support).
- Make decisions related to quality independently based on knowledge of regulations and compliance, and provide independent support to project teams.
- Conduct audits of internal quality system components in manufacturing and operational support areas.
- Oversee compliance with Change Controls, Corrective Actions/Preventive Actions (CA/PA), investigations, Out of Specification (OOS) results, and deviations. Also, conduct audits of suppliers, vendors, and off-site facilities.
- Act as the primary point of contact for customers during on-site audits, conference calls, and other communication methods.
- Identify and manage special projects or **QA compliance** functions independently, as agreed upon with **QA management**.
- Prioritize and manage multiple projects concurrently.
- May be required to lead and supervise the work of others.
- Review and approve validation documents.
- Review **Master Batch Records (MBR)** and associated documents.

**WHAT YOU SHOULD BRING WITH YOU ?**
- **GMP knowledge** and knowledge of **regulatory requirements**.
- **Direct QA commercial drug substance**/**drug product** or an equivalent amount of **aseptic processing** and cell therapy manufacturing experience at a minimum of **3-5 years** in a similar role, preferably gained in a **Life Sciences / Pharma / Biotech Upstream / Downstream environment.**:

- Language: Fluent in **German** and preferably in **English** required
- **60% on site**

**WHO WE ARE ?**

TechFirm is a 100 % Swiss headquartered and operating Engineering company founded in 1998, working from Geneva, Fribourg, Basel and Zurich offices with a team of 350 dedicated engineers. We operate in the Life-Sciences, Chemistry, Energy, Construction, Transport and Watchmaking sectors with our team of experts.

Techfirm Industrial Services is the dedicated division contributing on all elaboration phases of industrial investment projects:

- Concept, Basic and Detail Engineering,
- Support phase execution or Product Development;
- from Study and Conception stages to production tool maintenance, including Special Processes;
- Production and even Industrial Performance.

At Techfirm, we are committed to ensuring a healthy, motivating and dynamic working environment. So that everyone can fully develop, fell good and be happy going to work every morning. A company that is different: Human, in one word
- **Please note, that we can only consider Swiss or EU/EFTA nationals or applicants with a valid residence or work permit for Switzerland.**_

**Job Type**: 100%

Schedule:

- Monday to Friday

Work Location: In person

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