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10 Pharmazie Stellen in Hünenberg gefunden

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Sr Associate II Supplier Quality - Biotech

The main purpose of this job is to manage the QA interface with manufacturing and testing partners for assigned products and/or projects by ensuring quality of the product and/or process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements from API to FG manufacturing.

Sr Associate II Supplier Quality - Biotech

The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements. It includes quality management of the product lifecycle management in relation with contract manufacturing, and support to asset functions such as review and approval of regulatory filings.
Your primary responsibilities will be to (and are not limited to) for the assigned CMO sites:
• Be the point of contact for all Quality Matters
• Taking care of Deviation, complaints and CAPA: you ensure the tracking, timely and appropriate investigation, impact assessment, close out with involving partners and contractors. You ensure appropriate corrective and preventive actions are defined, implemented and that their efficacy is evaluated
• Provide technical support for the manufacture of product and ensure that the quality systems are maintained in the state of compliance
• Assist the audit team in audit preparation and participate in the audit execution; ensure that any commitments given to address audit observations by CMO sites are implemented as described in the agreed time frame
• Coordinate the preparation Regulatory Inspection of CMOs and internal departments. You perform risk assessments as preventive measures or in response to product/ quality system failures, investigations and regulatory inspections
• Ensure that periodic assessments are performed with a cross functional team as per procedure
• Responsible for quality aspects related to the transfer or set-up of processes, including but not limited to risk assessments, validations protocols and reports review and approval, defining and following up on quality and performance indicators
• Participate to cross-functional reviews of regulatory files prior to submission and to the preparation of annual product quality reviews
• Prepare, manage and maintain quality agreements with manufacturing and testing partners

Qualifications

• At least 4 years of experience in similar position in pharmaceutical or biotechnology industries 
• A first relevant experience in either manufacturing, development, quality or regulatory
• Good understanding of Quality Systems and Regulations (FDA & EU) – any other regulation system knowledge is a plus 
• Knowledge of medical device regulations and manufacturing is a plus.
• Excellent communication skills in English and Agility in leading Quality are part of the Success on this position

Education

University Degree in Scientific field (Pharmacy, Chemistry, Biology, Biochemistry…)