QC-Manager (with Focus on Drug Substance)

QC-MANAGER (WITH FOCUS ON DRUG SUBSTANCE)

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich, we are excited to help you in your search. We focus on finding the best contracts for the best contractors.

Randstad professionals are looking to find a responsible and open minded candidate who adds value to our client's team. Our client is an international pharmaceutical company.

JOB REQUIREMENTS

- Subject Matter Expert Support in Quality Control and stability related topics, investigations and issues.
- Provides quality oversight of QC related activities performed at CMOs for our clients products.
- Reviews and assesses QC activities at CMOs against cGMPs, regulatory dossiers, clients Quality Requirements and Global Standards and Practices
- Is responsible for the maintenance and revision of client's specifications and methods for products manufactured at CMOs including assessment and implementation of new regulatory requirements. Is responsible for the information of quality site management for implementation at the CMOs.
- Supports change control for Specifications, Analytical methods, Stability protocols, and other laboratory impacting activities. Supports the Local and Global Change Commission regarding changes in Analytics and Methods impacting a CMO.
- Reviews Release testing data to support qualification of CMO for independent raw data review
- Reviews CMO stability protocols and reports.
- Contributes to data trending activities.
- Support of analytical transfer activities (eg support in providing documents, samples, reference standards).
- QC support during Health Authority inspections and corporate compliance audits.
- Reviews the QC and Stability sections of Annual Product Quality Reports.
- Contribution to the elaboration of quotes/purchase orders for analytical activities.
- Analytical support for regulatory submissions and HA requests in collaboration with the product quality team.

JOB QUALIFICATIONS

- M.S. in Science or equivalent, Graduate degree preferred.
- Minimum of 3 years of experience in Quality Control or Analytical Development including Laboratory experience (activities or supervision)
- Strong knowledge of global pharmaceutical industry regulations, standards and guidance documents.
- Ability to communicate clearly and professionally both in writing and verbally.
- Flexibility in work hours and travel (up to 20%) to meet business objectives.
- Experience in working with multifunctional, multicultural, and global teams.
- Ability to speak English and another European language such as German, French or Italian preferred.
- Position is based in Basel, Switzerland

Want to experience Basel, gain international experience in one of the top cities in the world for quality of living and salaries, get in touch with our team of specialist.

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