- 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.
- 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.
- 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.