Manager Product Transfer QC

Manager Product transfer QC - 100%

For our Pharmaceutical client (Ophthalmics), we are looking for a Manager Product Transfer QC for a permanent role based in Winterthur.

In this interesting position you will be responsible for leading 2 teams (API transfer and finished products) responsible for analytical transfer and validation activities. In addition, you will be responsible for planning analytical activities with the help of an analytical transfer specialist. You will report directly to the Executive Director Quality of the site. We are looking for an initiative and dedicated individual, starting immediately or by appointment, who will be responsible for the following main tasks:

Duties and responsibilities:

• Personnel and technical leading of the Product transfer QC department
• Planning of analytical method transfer activities
• Ensure Transfer activities on time according to plan
• Presentation of the progress of the transfer-/validation activities in international meetings
• Coordination and control of activities like Changes and CAPAs
• Creation and review of transfer-/validation protocols and reports according to internal and international guidelines (EP, USP, ICH…)
• Control and coordinate troubleshooting activities concerning analytical deviations and OOS
• Review of SOPs and methods
• Review of qualification and calibration documents for laboratory devices / laboratory systems
• Assist in Strategy product transfer planning activities global and local level

Qualifications:

• Completion of a university degree in chemistry with several years of professional experience
• Well-founded GMP experience and good knowledge of instrumental analysis (e.g. HPLC, GC and Particle Size Distribution with Mastersizer 3000)
• Profound knowledge in the validation of methods or in their transfer and verification according to USP and additionally in the qualification of laboratory equipment
• Leadership experience
• Good spoken and written German & English knowledge
• Good knowledge of IT (MS Office etc.)
• Knowledge of the use of a CDS and Quality IT-systems
• Knowledge of Lean Management for Laboratory Excellence programs is desirable

Experis is the global leader in professional resourcing and project-based workforce solutions.

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23