Job Description

A fantastic opportunity has arisen for a Data Reviewer-Pharm Ops.

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

Data Reviewer is responsible for ensuring all testing activities comply with cGMP.Review batches for assigned processes in accordance with regulatory and compendia requirements and to support Internal and Customer Services targets.Support Laboratory release of Raw Materials/Excipients/Components and Drug products and by the review of test packages.Review all documentation issues with analysts and improve RFT throughout the laboratory.Compile and complete all required laboratory metrics.Deputise for the Laboratory Co-Ordinator in event of absence and attend Tier meetings as required. Review of data generated by outsourced laboratory for release of Raw Materials/Excipients/Components.Review of training to ensure that Analysts can execute the testing function in accordance with company requirements.Identify and implement improvements for laboratory systems and develop/update procedures/SOPs as required.Participate in and review Laboratory investigations.  Follow-up on corrective actions.When required assume the role of auditee for the group for internal and external Audits.Ensure that corrective actions as a result of audits or deviations are completed and that responses are filed as appropriate.Ensure sufficient supplies of standards/comparisons, disposables, reagents and any special requirements.Be an active member of the group.  Provide support and leadership to the group in team building, release, safety, compliance and improvement objectives.

What skills you will need:

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

Minimum education qualifications for this role are Life Sciences degree, or equivalent.Procedures policies and guidelines relevant to responsibilitiesLaboratory testing and documentationData integrity requirements including ALCOA and electronic review of data.GMP experience.Change Control and Deviation system operations and product quality impact.Current regulatory environment and regulations/requirements

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, 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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/15/2025

*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:R334104