What are the responsibilities and job description for the Director, Quality Control position at Siegfried?
Manage quality control activities related to chemistry, microbiology, and raw material inspection testing for all product lines. Supervise the microbiology, chemistry and QC Raw Materials laboratory staff.
Responsibilities
- Develop and improve analytical test methods for incoming material, in-process and final product release.
- Develop and implement quality control standards.
- Ensure adherence of all QC staff to quality (GMP) and safety (SHE) requirements at all times.
- Manage resources and schedule tests in chemistry and microbiology labs to ensure on time execution.
- Collaborate with QA, MS&T and Engineering groups to develop and finalize testing requirements and specifications for incoming material, in-process and final product release criteria.
- Identify process and quality problems, recommend solutions, develop or recommend process improvements and assist with implementation in QC.
- Interact with contract test laboratories in development of off-site test methods. Oversee routine external testing performed at contract test laboratories.
- Interact with customer on contract testing services provided by the chemistry and microbiology laboratories.
- Oversee and delegate the necessary testing in the microbiology, chemistry and raw materials laboratories.
- Review and verify analytical test results from both in-house and contract laboratories.
- Write, revise, review and approve documentation related to test method validation/verification and stability.
- Oversight over stability program for internal and customer projects, manage or delegate oversight of the LIMS stability database for stability time points and inventory. Manage the availability of the stability chambers and incubators.
- Execute responsibilities as QC Director in Labware LIMS. Oversee inspection, sampling and testing of raw materials and final products.
- Support Cleaning Validation Program
- Acquire and qualify new equipment for testing of Raw Materials and Finished Products.
- Support all regulatory submissions of the customers.
- Support regulatory inspection and customer audit activities.
- Provide leadership, development and direction to the microbiology, chemistry and raw materials laboratory staff and supervisors.
- Hire staff that is technically capable to carry out the related job duties.
- Manage the headcount and laboratory supplies according to requirements and the agreed annual budget.
- Support the annual budgeting process for headcount, materials and maintenance costs as well as CAPEX.
- Collect and evaluate KPIs (key performance indicators), report to senior management and global head of QC. Devise and implement corrective actions where necessary.
- Be part of the SLT (site leadership team) and collaborate with peers to improve the efficiency of the site.
- Be part of the Global Analytics team and exchange with peers from other sites to harmonize processes, support and learn from best practices.
- All other duties assigned by the immediate supervisor.
