Our client is seeking a skilled Supplier & Material Qualification Specialist to join their BIO Mammalian team for a 6-Month contract to ensure the efficient and compliant supplier and material qualification process in line with regulatory requirements, corporate standards, and agreements with stakeholders.
The successful candidate will manage key performance indicators (KPIs) and escalate any risks or issues related to suppliers and materials, ensuring timely resolution.
Key Responsibilities:
- Establish and maintain raw material suppliers, SOPs, and systems.
- Oversee the qualification of materials used during the manufacturing process.
- Ensure qualification of suppliers and service providers meets the required standards.
- Maintain and ensure the accuracy of supplier and material data within quality systems such as SAP and TrackWise.
- Manage change notifications and quality alerts from the Client Network.
- Handle deviations and changes associated with suppliers and materials.
- Collect and organize KPIs linked to material and supplier performance for monthly quality councils.
- Ensure timely escalation of critical quality issues related to suppliers or materials, ensuring compliance with GMPs.
Other Requirements:
- Support activities related to the qualification of service providers (e.g., audits).
- Act as a deputy for material release in LIMS.
- Act as a deputy for special usage decisions of materials.
Required Skills:
- Strong knowledge of GMP regulations and pharmaceutical quality management systems
- Minimum of 3 years of experience in material and supplier qualification
- Proficient in SAP and LIMS quality systems
- Experience in managing quality tools such as deviations, CAPA, and change controls
- Excellent problem-solving and decision-making skills, particularly in high-pressure environments
- Required: Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
- Preferred: Master's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
- Fluent in English and German is a plus
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!
