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Supervisor QC - Switzerland  

Company managed [?] Still accepting applications

Posted on : 05 April 2017

Project Description

 About Us
  • Our company  is a research-driven, specialty biopharmaceutical group active in global markets.
  • The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics. 
  • Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.



Role
  • Assisting in the management of the daily activities of QC lab in support of routine production and instrument maintenance. 
  • Be a project leader for QC projects such as new technology, new methods, training, new staff and collaborations between laboratories and sites. 
  • Be responsible for Lean and Six-Sigma projects within QC. 
  • Be a trouble shooter and support the operational part of QC. 
  • Write reports and protocols for trends, qualification and validation. 



Main Responsibilities 
  • Supervise the daily routine activities within QC. Make plans according to the requirements from production, logistics, R&D and other QC customers.
  • Supervise timely implementation of the analytical testing and documentation in laboratory. 
  • Approve/review the testing records, analytical data or other GMP sample documents.
  • Supplying the technical guidance to the staff in the laboratory. 
  • Ensure training plan for QC staff and carry out training of QC staff , both for GMP and improving technical skills and know-how. 
  • Support that compliance and GMP level of staff is high.
  • Review and approve in LIMS and Oracle for the production, and facilitate timely creation of COA's for QA release. 
  • Assist in the development and changes to the electronic sample handling systems.
  • Participate in recruitment of new staff, performance evaluation for subordinate, budget plan.
  • Supervise the maintenance and calibration program for all equipment and instrument according to SOP requirements. Write and update SOP's
  • Planning, implementation and documentation of validations of methods and qualifications of instruments. 
  • Prepare URS, Protocols and reports. Support QC's part in the stability testing program. 
  • Write APR reports and be responsible for trending of data.
  • Participate in the preparation of specifications from standards (EC Guide, ISO, DIN, NIST, etc.) for calibration, qualification and validation process in consultation with QA and QC staff.
  • Be a project leader for new technology, Lean, Six Sigma or other QC relevant projects.
  • Deputize for the QC Manager when needed. 



Required Experience & Skills 
  •  Bachelor's degree, Engineer or above in pharmaceutical analysis, pharmacy, analytical chemistry, microbiology or related majors
  •  At least 3 years experience in similar field of a pharmaceutical laboratory
  •  Experience with GMP guidelines and documents
  •  Be familiar with Oracle and LIMS
  •  Leadership skills, Management skills
  •  English: spoken and written.
  •  Good troubleshooter
  •  Extrovert, good coaching skills and communicator
  •  Structured and experienced in creating GMP documents.