For its pharmeutical partner specialized in Medical Devices, Kelly Scientific is looking for:
Analytical Development and Quality Control Laboratory Manager
(6 months temporary position)
Your responsabilities :
- Responsible for managing the QC and analytical laboratory in accordance with cGMP and company requirements,
- Responsible to resolve problems with instruments, test methods, lab chemicals, standards, and samples,
- Overall responsibility for development and validation of innovative analytical methodologies, and support method transfers as needed
- Responsible to assure that all raw materials and finished goods are tested in accordance with GMP,
- Responsible to release raw material,
- Organize and supervise the scientific activities carried out on the analytical techniques available in the laboratory (LC-MS, GC-MS, FTIR, …),
- Manage stability study protocol development, execution, data analysis and reporting
- Support continued business process improvement activities.
- Cultivate and maintain relationships with key internal and external customers
- Initiate Change Controls to support change of equipment, specification documents and test methods, ▪ Provide technical support to other QC activities as business needs arises.
- Maintain training records current and GMP compliance.
- Bachelor or Master degree in Chemistry, Pharmacy, or Biochemistry
- Minimum of 5 years' experience in QC and/or analytical development in biotech or pharmaceutical industry (GMP environment)
- Experience in management; demonstrated leadership and organization skills
- Deep knowledge of a variety of analytical techniques such as HPLC, GC, FTIR, and other analytical techniques.
- Experience in analytical investigations, handling of OOS, OOT investigations
- General knowledge of the ICH guidelines and of the major pharmacopoeias
- Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels
- Strong communication and technical writing skills.
- Fluency in English (both oral and written)
- Extremely motivated, with rigorous work habits and problem-solving skills
Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva