Specialist Quality Assurance

Job Title: Specialist Quality Assurance

Work Location: Lucerne

Country: Switzerland

Duration: 12 months

Rate: Up to CHF63 phr (8 Hours per day)

Your main duties as an Specialist Quality Assurance will include:

• Reviewing batch records of clinical supplies which are packaged locally and at CMO, working environment with multiple stakeholders in multiple countries.
• Review, and releasing of clinical finished goods, including reviewing of the printed and applied label.
• GMP reviewing of the batch record and reviewing of the regulatory filings and the final release.

Additional duties will include:

• Collaborating closely with internal functional areas, such as GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality.
• Communicating batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP).
• Supporting in Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensure quality compliance and/or identify potential area of improvements.

Your Background:

• Bachelor s or Master s Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies.
• Master s Degree in clinical research, clinical data or clinical analysis is also advantageous.
• Minimum of 2-years experience in GMP environment within the pharmaceutical business or comparable.
• Experience in batch record review is strongly recommended.
• Demonstrated problem-solving skills, preferably with Six Sigma Tools.
• Preferably SAP and MS Word/Excel Experience.

Languages:
Good level of English (C1), German is an added benefit.

Apply:
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 107671 in all correspondence.