Senior QA Expert - 6922– ADA, Stein

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a

Senior QA Expert for a contract role until the end of the year with potential extension. This role is an onsite role based in Stein, Switzerland with maximum 1 day home office possibility with agreement.

Main Responsibilities

Management and maintenance of quality assurance activities by supporting operational departments in accordance with agreed timelines as well as global and local standards to ensure the GMP compliance within sterile manufacturing.

Act as Quality single point of contact for the activities assigned

Author, review and approve deliverables included but not limited to, such a SOPs, gap assessments, risk assessment, cleaning documents, WI)

Coordinate, review and approve quality records included but not limited to, such as deviations, CAPAs, change controls, qualification and validation documentary) related to the manufacturing processes in Trackwise and KNEAT.

Participate and provide support to Growth Projects 41X operational departments in alignment with cGMP

Serve as QA oversight to ensure GMP compliance within manufacturing activities.

Support SMEs during investigation, included but not limited, such as root cause analysis, impact assessment, action plan implementation.

Participate in quality systems improvements projects and lead lean improvement projects to ensure efficiency in alignment with global and local standards

Monitor local and global meetings as well as project progress to ensure efficient and effective communication on project status

Liaise with external partners/customers to set up a release strategy for deliverables in alignment with corporate standards as well as global and local standards

Deliver expertise in all matters concerning cGMP compliance as required

Define, manage and report Quality Key Performance Indicators (KPI), as needed.

Perform other agreed activities as assigned by the line manager.

Execute, improve and maintain the Quality Oversight concept within DPS manufacturing.

Provide QA support to Drug Product network

Qualifications and Experience

Relevant working/residency permit or Swiss/EU-Citizenship required

University or academic degree (Master or Ph.D.) in Chemistry, Biology, Pharmacy or equivalent

5-10 years of experience in

Quality Assurance or Quality Control

in a

manufacturing environment

within Pharmaceutical Industry

Superior problem solving, decision making and planning skills

Sets clear priorities for task for him/herself and the team

Customer oriented and collaboration with Process Unit team

Sound knowledge of

cGMP and regulatory compliance

of all relevant operations in the Process Unit

Excellent English skills (spoken and written), German skills an advantage

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