For our customer located in Basel/Switzerland we are currently looking for (m/f) an QA / QC Expert
- Type of placement: 12 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 2, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Provide QA oversight on all external suppliers for BDSS. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management at BDSS.
- Responsible for initiating and driving supplier qualifications
- Upgrade of supplier qualifications from clinical to commercial in scope of the BDSS going commercial project
- Upgrade of raw materials and consumables from clinical to commercial in scope of the BDSS going commercial project
- Oversight on all suppliers and raw materials used at BDSS
- Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
- Manage and evaluate change notifications from external suppliers
- Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
- Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs...)
- Manage projects, and provide QA support. May provide functional expertise in area of responsibility (supplier qualification).
- Represent BTDM BDSS Quality in initiatives. Liaise with key stakeholders across NTO to identify compliance standardization needs.
- Lead project related activities (e.g. development of new tools and processes).
- Provide support to BTDM BDSS line functions in GMP compliance related issues in area of expertise.
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines.
KEY PERFORMANCE INDICATORS / MEASURES OF SUCCESS
- Supplier oversight and supplier approval rate
- In accordance with BDSS objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections.
- Act in accordance with our customer standards, in particular ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
- Maintain sound working relationships with partners and customers.
- Feedback from other team members
- Meet quality and timelines in all projects
EDUCATION / EXPERIENCE
o Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
o Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
o Fluent in English (oral and written) required; fluent in site-language desirable
- Experience/Professional requirement:
o At least 3 years of relevant experience.
o Strong ability to negotiate and communicate.
o Good team working skills
o Sound scientific, technical and regulatory knowledge.
o Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
o Good knowledge of drug development and drug substance production.
o Good organizational skills.
o Good and proven ability to analyze and evaluate GMP compliance.