QA Officer (18 month contract)

• Ensure that all batch related records are reviewed and approved in a timely manner for completeness, accuracy and adherence to Good Documentation Practices (GDP).
• Conduct final review of Seed folders and convey Seeds status to relevant departments.
• Communicating with departments with regards to documentation status; maintaining the document management system (MIDAS) by assisting with the review and approval stages.
• Responsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA Management
• Implementation of global and site quality procedures.
• Supporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closure.
• Raising non-conformities, technical incidents and taking suitable and appropriate corrective actions.
• Participate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrence.
• Mentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environment.
• Perform internal audits
• Maintain and promote a state of audit readiness.

Qualifications:

• Relevant degree in a life science discipline, with experience of working in a cGMP environment and working within a Quality Management System.
• Proven industry experience in Quality Assurance within the Pharmaceutical industry; experience with production of a Pharmaceutical product would be desirable.
• A working knowledge and practical experience with the regulatory requirements for manufacture of licensed medicinal products.
• Internal Audit Experience desirable.
• Good communication skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R126139