Assoc Quality Assurance Specialist

3 weeks ago

ballydine the borough district of clonmel ireland MSD Full time

Job Description

An amazing opportunity has arisen for an Associate Quality Assurance Specialist.

What You Will Do

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

  1. Participate as functional expert in the cross functional team that manages production right first time at site.
  2. Review and approve batch, cleaning and testing documentation.
  3. Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
  4. Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
  5. Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
  6. Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
  7. Ensure changes controls raised are documented, assessed and completed.
  8. Prepare Annual Process and System Reviews.
  9. Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
  10. Participate in the generation and communication of quality metrics.
  11. Creation, review and approval of quality procedures as required.
What Skills You Will Need

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

  1. Degree or post-graduate qualification in Science, Pharmacy or equivalent.
  2. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
  3. Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  4. Experience and knowledge of GMP Requirements for Electronic / paper free operations.
  5. Experience in any of the following High potency / Spray drying / Laboratory / API / Oral Solid Dose / Project Management desirable.
  6. Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately.
  7. Interacts with people effectively. Able and willing to share and receive information.
  8. Uses sound judgement to make good decisions based on information gathered and analysed.
  9. Adapts to changing work environments, work priorities, organizational needs and diverse people.
  10. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
  11. Displays energy and enthusiasm. Maintains high level of productivity and self-direction.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

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.

So, if you are ready to

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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: Regular

Relocation: Not Applicable

VISA Sponsorship: Not Applicable

Travel Requirements: Not Applicable

Flexible Work Arrangements: Not Applicable

Shift: Not Applicable

Valid Driving License: Not Applicable

Hazardous Material(s): Not Applicable

Job Posting End Date: 02/25/2025

A job posting is effective until 11:59:59 PM 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.

Requisition ID: R333735

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