3 days ago

QA Compliance Officer - Facility

Glenmark Pharmaceuticals S.A.

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Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a research-led, global, fully integrated pharmaceutical company. The group is present in more than 40 countries including the USA and Europe. Our Swiss operation encompasses the Company’s Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. We provide an attractive, international and multicultural research environment with career opportunities for scientists engaged in applied biomedical sciences. Located in a beautiful area of Switzerland, we are a rapidly growing company with an attractive and competitive early research and development portfolio in the areas of immuno-oncology, respiratory and dermatology research.

QA Compliance Officer - Facility

Glenmark Pharmaceuticals www.glenmarkpharma.com is a research-led global fully integrated pharmaceutical company. The group is present in more than 40 countries including the USA and Europe. Our Swiss operation encompasses the Company's Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. We provide an attractive international and multicultural research environment with career opportunities for scientists engaged in applied biomedical sciences. Located in a beautiful area of Switzerland we are a rapidly growing company with an attractive and competitive early research and development portfolio in the areas of immuno-oncology respiratory and dermatology research. QA Compliance Officer Facility RESPONSIBILITIES

Execute facility-specific Quality Assurance activities such as equipment/system validation in order to meet the defined agreements.
Optimize facility quality processes based on EP/USP GMP guidelines.
Draft facility Quality Assurance policies and procedures.
Review and update validation master plan and system/equipment qualification as well as organize training interventions.
Provide support for on-site audit inspections.
Responsible for the monitoring of deviations CAPA changes Investigations and audit findings.
Responsible for the review of facility validation studies facility standard operating procedures and environmental programs.
Interpret and report results of work in both written and oral format including support on regulatory advice to Glenmark employees.
Assist in the improvement of quality procedures and the quality manual in order to meet current guidelines.
Plan conduct and monitor testing and inspection of materials and products to ensure quality of finished product.
Advise on potential improvements to the quality system and on revisions to quality procedures.
Provide support for internal and external audits and QA on the floor during manufacturing process.
Perform other relevant duties as required.


REQUIREMENTS

BSc MSc or equivalent in biochemical engineering biochemistry biology pharmacy or related discipline
Minimum of 5 years of relevant experience in an industrial setting under GMP
Relevant QA experience and knowledge of current Swissmedic USP EP and ICH guidelines
Experience in Cleanroom Engineering Manufacturing Computer Validation and Systems Qualification
Experience in change control and deviation management
Excellent interpersonal and communication skills
Ability to work both independently as well as part of a team
Demonstrated skill in planning and organization customer service problem analysis/solving and proactivity
Fluent English is required both written and verbal proficiency in French is highly desirable

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