Associate Quality Assurance Specialist

3 days ago

Nenagh, County Tipperary, Ireland Merck Gruppe - Msd Sharp & Dohme Full time

Job Description
An amazing opportunity has arisen for a Assoc.
Quality Assurance Specialist responsible for the Quality Documentation Control Systems.
What you will do: Bring energy, knowledge, innovation and leadership to carry out the following:
Responsible for the control, operation and maintenance of the Quality Documentation Control Systems including: Quality Docs, MIDAS, MEDS and Elogs.Site subject matter expert and system owner for Quality Docs, MEDS and Elogs.Oversight of the site documentation periodic review cycles such as procedures and job descriptions.Working collaboratively to support site regulatory inspections (i.e.
FDA, HPRA, Corporate, Customer, etc).Presentation of the documentation Quality Management Systems during inspections.Participate in the generation and communication of quality metrics.Participate in Quality and site projects that may arise.Support the Site Topic Lead program.Generation of new and periodic review and update of Technical Quality Agreements.Be a document system expert, this will include training new users in the requirements of the documentation systems, ensuring that the site complies with data integrity requirements applicable to forms, logbooks, templates, continuous improvement of the site procedures, forms, logbooks, templates, ensuring right first-time execution of the generation, review and approval processes associated with Quality Management Systems documentation such as SOPs, Work Instructions, Reports, etc.What skills you will need: In order to excel in this role, you will more than likely have:
Degree in Science or related discipline.1-3 years' experience within the Pharmaceutical industry in a Quality Assurance role.Strong document control experience.
Experience using Veeva Vault an advantage.Digital proficiency: MS Teams, SharePoint, Word, Excel, PowerPoint.Knowledge of EU/US quality related pharmaceutical regulations, especially Data Integrity requirements for GMP documentation.Excellent written and oral communication skills.
Organizes and delivers information appropriately.Interacts with people effectively.
Able and willing to share and receive information.Uses sound judgement to make good decisions based on information gathered and analysed.Adapts to changing work environments, work priorities, organizational needs and diverse people.Sets and maintains high performance standards.
Pays close attention to detail, accuracy and completeness.Displays energy and enthusiasm.
Maintains high level of productivity and self-direction.
Is result oriented.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: 03/22/2025
*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: R339691

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