MSD QA Operations Specialist 

Ireland 

600486640

Job Description

Biologics facility.

Reporting to the QA Operations Manager within Global Development Quality (GDQ), the QA Specialist role will support the Quality Assurance activities at Research & Development Division facility.

The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. Our site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.

The QA Operations Specialist is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. The QA Operations Specialist will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The QA Operations Specialist will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. The QA Operations Specialist will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner.
• Participating in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented to meet deadlines.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements.
• Provide QA oversight to thequalification/validation,technical transfers, regulatory approvals, laboratory operations and commercial operations.
• Complete QA operational duties related to product disposition including a detailed and timely review of batch documentation (EBRs) prior to QP release.
• Perform material disposition of incoming material to the site.
• Assist in the development of training curricula and records for the QA Operations group, providing SME training on Quality Assurance SOPs as required.
• Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Ensures the escalation of compliance risks to management in a timely manner.
• Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
• Support cross functional departments by responding to quickly to unplanned events and technical issues.
• Perform real time exception review by maintaining on the floor operations support during manufacturing.
• Support the site’s walk-through/ GEMBA process as assigned.
• Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree qualification (Science/Quality/Technical).
• 4-7 years’ experience,ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Experience with MES, SAP and Veeva is desirable.
• Project Manager capability with significant understanding of Operations and/or Laboratories.
• Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
• Strong written and verbal communication skills.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Experience in direct interactions with regulatory agencies during site inspections.

So, if you are ready to:

Current Contingent Workers apply

*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.

Job Posting End Date:07/02/2024

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.