Quality Assurance Associate

vor 1 Monat

Zurich, Schweiz two.jobs Vollzeit

Für unseren Kunden Selectchemie AG suchen wir eine/n Quality Assurance Associate (100%)

About Selectchemie AG

Selectchemie AG is an independent Swiss company and since 1969 a first class distributor and service provider for the global Pharma and Swiss Nutrition industries. As exclusive distributor for leading suppliers of raw materials, APIs and excipients, complemented with our offering of boutique generic finished drug forms, we add value to our customers based not only on our products, but also with regulatory, quality, technical and supply chain services.

Join our team

Selectchemie is our customers’ partner for reliable commercial supply of our Finished Dosage Forms products (FDF). In addition to our robust supply chain we create value to our FDF customers with our Quality Assurance and Regulatory Affairs activities pre-launch, and during the entire commercial phase of our FDF products.

You are a proven QA expert with a wealth of experience in the manufacturing pharmaceutical industry of generic drug product for a global clientele.

Based on your experience you are an efficient and pragmatic solution thinker and proficient in communicating your ideas and solutions to internal and external stakeholders like project managers, CDMOs, and customers/licensees.

Your exact, reliable and professional work is the basis for your efficient work to ensuring our FDF products’ quality and our regulatory task and support of our customers/licensees.

Aufgaben
- PQR preparation and customization if necessary
- Deviation/complaint management: Support handling, responding, tracking of any FDF related deviation and/or complaints being received by any customer or contract partner according to the internal procedure. Ensure good communication between the involved parties (internally and externally). Participate in deviation/complaint investigation to the extent required.
- Batch record review: Review CMO provided batch documentation according to the internal procedure. Request missing documentation and clarification if required. Continue monitoring.
- Harmonization of quality technical agreements
- CMO and service provider qualification: Perform and/or participate in CMO and service provider qualification (e.g. participate in CMO audits). Qualification follow-up (CAPA; organization of re
- audit)
- Documentation management: Review/prepare/approve SOP concerning FDF activities; assess products and CMOs in quality management review; supervise on-going stability program; review and release transport monitoring; release of secondary packaging material specification; release of secondary packaging material for further processing

Qualifikation
- University degree in Pharmacy, Chemistry, Biochemistry or Biotechnology
- Good knowledge of EU GMP regulations
- At least 3 years’ working experience in medicinal products’ manufacturing pharmaceutical company, particularly in quality assurance area. Experience in production is of advantage
- Experience in product quality reviews preparation, deviation and change control management, batch record review
- Previous experience with harmonization of quality technical agreements and supplier auditing is of advantage
- Excellent communication, project management, planning, problem solving and presentation skills
- Flexibility to work in a global regulatory cross cultural work environment and ability to work independently as well as in a team
- Fluent in English, German is a plus

**Benefits**:

- Entrepreneurial position in a dynamic globally acting team
- Your input is key and your part of creating our future success
- Intense cooperation with colleagues and across the entire hierarchy within Selectchemie
- Intense cooperation with CDMOs, customers/licensees on a global basis
- Short decision processes
- Attractive compensation package and remote working if you are not based in Switzerland
- Travel of about 10%

Bitte stellen Sie uns mit Ihrem Lebenslauf auch Ihre Zeugnisse und Diplome zu. Herzlichen Dank vorab

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