MSD Specialist Clinical Supplies QA m/f/d 

Switzerland, Lucerne 

512711080

Job Description

Responsibilities:

• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies and procedures of our Company and compliance with all governing regulations.

• Coordinate and support the preparation of procedures, processes and quality improvements.

• Assists in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine and recovery actions.

• Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.

• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.

• Actively using and championing the use of Lean Six Sigma and our Company's Production System tools, both in problem solving and day-to-day operational activities.

Education:

• Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred.

Required Experience and Skills:

• Minimum of two years' experience in the pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Basic understanding in using Microsoft applications (such as Excel, Outlook, PowerPoint, Teams and/or Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as stakeholder management and conflict resolution skills.

• Demonstrated teamwork skills and ability to work independently.

• Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred Skills:

• Familiarity with batch disposition (release) activities is strongly preferred and prior batch disposition experience is a plus.

• Prior experience reviewing and approving investigations, deviation management and Corrective and Preventive Actions (CAPAs).

• Previous background in quality control, quality assurance, auditing or regulatory affairs.

• Ability to independently manage multiple priorities and projects.

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

• Demonstrated analytical and problem-solving skills, knowledge of Lean Six Sigma and Project Management.

• Computer skills; knowledge and competency in Enterprise Resource Planning and Deviation Management (SAP), VeevaVault and TrackWise.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

What we look for …

Current Contingent Workers apply

Not ApplicableNot Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.