MSD Looking for QA Officer Milton Keynes 2023 at Milton Keynes Full Time

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Position Overview

• Supported by the Quality Compliance Team and the Quality Systems Team and the Qualified Persons located in Milton Keynes, provides Quality Assurance support to the Milton Keynes operations.
• Working with the site management, ensures that the production operates in a fully GMP compliant manner in accordance with the relevant corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the product and processes are fully compliant with the filed regulatory dossiers for the products supported.
• Support the site during compliance inspections including internal and corporate audits as well as Regulatory Inspections.

Role and Responsibilities

• To make sure all batch related records are reviewed and approved in a timely manner, including the review of any deviations relating to that record.
• Communicating with departments with regards to the status of batch documentation.
• Assist in SBB, NSBB, FPU, QC
• Maintain change control system, working with departments to assess the impact, and ensuring their timely review, implementation, closure.
• Be the quality representative for investigation, working with departments on assigning actions, raising CAPA’s and change control were applicable.
• Perform internal and external inspections and audits
• Participate in regulatory inspections as required
• Perform VMD amendments
• Contributing on RegDat project improvements

Qualifications, Skills & Experience Required

• Typically, a graduate, or equivalent, with experience of cGMP and working within a quality management system.
• Some experience within the Pharma industry, with preferably Quality Assurance, Quality Control or production experience

Preferred skills

• Demonstrated knowledge and understanding of current regulatory requirements for manufacture of licensed medicinal products.
• Internal Audit Experience desirable
• Problem solving and good communication skills.
• Technical report writing and database management.
• Knowledge of pharmaceutical manufacturing

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.