Job Description
An amazing opportunity has arisen for the role of QA Validation Associate Specialist within at our state-of-the-art single use biologics facility in Dunboyne, County Meath, Ireland.
What you will do:
Bring energy, knowledge, innovation and influence to carry out the following:
- Quality oversight of GMP compliance for engineering and validation deliverables related to projects including requirements definition, specification, engineering design, qualification and change management.
- Quality oversight of Shipping Qualification deliverables.
- Quality oversight of Maintenance & Calibration program.
- Quality oversight of Pest Control Program.
- Providing support for Permanent Inspection Readiness Program, in preparation for agency inspections, as well as supporting Internal Audit Program as required.
- Providing support for Annual Product Quality Review and performing quality assessment for all engineering and manufacturing changes associated with validation activities.
- Review and approval of validation protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
- Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
- Collaboration and participation in projects as a Quality Representative for Validation.
- Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment & systems.
What skills you will need:
In order to excel in this role, you will more than likely have:
- Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc).
- Minimum of 3 years’ experience in a QA/Validation related position within the pharmaceutical Industry.
- Experience with Validation in project related activities, including Controlled Area Facilities.
- Experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
- Excellent communication skills (written and oral).
- Ability to multi-task and handle tasks with competing priorities effectively.
- Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures.
- Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
- Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
- Ability to interact with multiple stakeholders within the business.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/24/2024
*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.
Job Posting End Date:09/24/2024
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.
Requisition ID:R307423