Philogen S.p.A. would like to hire a Biochemical Quality Control Manager who will report directly to the Quality Control Manager.
In particular the successful candidate will be Responsible for:
- Biochemical laboratory functions and the corresponding documentation to support the timely disposition of product.
- Overall Quality control disposition of incoming materials, in process samples and finished products.
- Analytical method set-up, validation, trasfer and writing reports.
- Management of site products stability studies.
- Reviewing and approval of the entire SOPs relating to Quality control tasks and ensuring understanding and implementation of these SOPs.
- Insuring compliance of laboratory procedures and practices with Philogen Quality standards and with GMP and GLP regulations.
- Support to the critical quality attributes identification and control strategy definition.
- Supporting laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
- Support day to day scheduling activities closely with the QC manager.
- Facilitating continuous improvement in QC day to day operations and general systems and will actively support achievement of plant goals.Coaching and developing QC colleagues to achieving high performance.
- Promote the technological innovation, scientific understanding and best practies, to design an integrated analytical development strategy, within the QC manager.
- Assist with regulatory agency inspections as needed.
The ideal candidate should have:
- A good scientific background.
- People management experience.
- Comprehensive knowledge of GMP.
- Minimum 5 years’ experience in Biochemical Quality Control management in pharmaceutical industry field.
- Knowledge of the following analytical techniques: E.L.I.S.A. immunoassays, SDS-PAGE Electrophoresis, Size Exclusion Chromatography/ Cation Exchange by HPLC, GC, chemical-physical analytical determinations, bioassay, cells proliferation assay, cell culture, real time PCR, raw materials analysis.
- Knowledge of method validation and trasfer, in compliance with EP/USP.
- Good in-depth knowledge of quality process control and statistical techniques.High analytical skills.
- Communication & high interpersonal skills.
- Problem solving skills.
- Good planning and organization capabilities.
- A high level of attention to detail and the ability to prioritize working tasks.
- High level of initiative and focused on improvement.
- Good English knowledge.
We offer:
- A dynamic environment.
- A permanent contract with a salary proportional to the experience level of the successful candidate.
Job location:
Siena – Italy