GENERAL POSITION SUMMARY
Quality Control Manager leads the lab team by developing and executing strategic plans for lean and continuous improvement, provides direction for organizational structure, GMP and safety strategy, promotes people training and development.
DUTIES & RESPONSIBILITIES
- Has full responsibility for the quality control of the whole manufacturing process from sampling and testing of incoming raw materials to final product release results.
- Together with the Quality Unit Manager and the colleagues in the Mgmt Team, formulates strategies and makes decisions which ensure efficient operations.
- Ensures that all components, in process controls and test results are released in accordance with local / international regulations and site policies.
- Distributes tasks to his subordinates and optimizes the efficiency of the team formulating KPIs to support strategic objectives.
- Improves quality results by implementing analytical methods, programs and procedures and ensuring instrument upgrades where needed.
- Writes and/or review laboratory relevant SOPs and all the analytical work-related documentation.
- Writes and/or review method transfer (protocol/report) and method validation documents.
- Ensures proper execution of utilities and environmental monitoring programs.
- Manages the stability studies programs.
- Ensures that lab processes are lean and that all lab activities are performed with a strong focus on continuous improvement.
- Support the Quality Unit Manager and the Site Head to establish operating budgets.
- Ensures that all activities are performed according to the site Quality System and SOPs.
- Manages test failure investigations and solves analytical problems and discrepancies.
- Ensures compliance to the internal policies for handling with OOS/OOE/Deviations.
- Ensures that deviations are investigated and followed-up in a scientifically sound and timely manner according to SOPs.
- Ensures that appropriate CAPAs are defined and implemented in due time.
- Ensures periodic spot inspections.
- Supports internal audits and external inspections (e.g., contract labs and suppliers).
- Supports the Quality Unit Manager during Health Authorities’ and Client’s audits.
People & Culture:
- Provides leadership, direction and support of the team members ensuring that they are adequately trained and qualified to perform the assigned tasks.
- Transfers knowledge and expertise to further empower lab team members.
- Supports the Quality Unit Manager in developing and implementing appropriate training programs for the lab team members.
- Creates a positive working environment by providing honest and immediate feedback.
- Ensures that performance review process for all team members is executed.
- Participates in the recruitment process to contribute to the hiring of the right people.
- Ensures compliance with the health & safety site instructions encouraging and monitoring, in particular, the proper use PPE (Personal Protective Equipment).
- Informs promptly the HSE in case risks and abnormalities potentially impacting the safety at work are identified and detected.
- High flexibility.
- Hight attention to GMP, HSE and QA.
- Challenges established procedures, initiating new and better ways of doing things.
- Sets clear priorities.
- Leads by example.
- Has good interpersonal and communication skills that make him capable to listen to the team members’ concerns, to adapt the communication based on each member’s personality style and to manage conflict in a way that all parties experience a satisfactory outcome.
- Provides, to help the team members to develop to their full potential, frequent positive and constructive feedback in a way that motivates both under-performing and high-performing people.
Chemist, Pharmacist, Biologist as ideal background. Equivalent or similar education supported by a consistent experience in pharmaceutical industry is also accepted.
English fluent in speaking/writing. Local language.
min 5 (five) years Quality Control experience in pharmaceutical industry. Knowledge in GMP, HSE and QA, analytical technology, and equipment
Application, completed with letter of motivation and CV, have to be sent to email@example.com