Spclst, Quality Assurance

Job Description

This position reports to the Associate Director, In-Market Quality Country Lead.  

The following core responsibilities are generally applicable to the In-Market Quality Assurance Specialist role:

• Under local Quality Responsible Person (QRP) responsibility, contributes to ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model

• Supports the implementation and maintenance of a quality system as pertains the activities in scope;

• Ensures that the applicable procedures are maintained applying risk management and continuous improvement principles;

• Supports the development and maintenance of local Quality training program as pertains the activities in scope, including assessment of training effectivenes;

• Contributes to ensure Quality perspective is brought into local business initiatives with Quality impact;

• Has the Quality oversight on management of relevant customer compliants;

• Deviation management, overview and tracking;

• Handling of temperature excursions during transportation, warehousing and distribution

• Oversight of repackaging/re-stickering activities performed by the appointed 3rd party logistics (3PL) provider

• Management of returned goods

• Pharmaceutical Evaluation of Tenders

• Participates in the process of importation of non-registered product in country

• Ensures that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place

• Supports due diligence and audits to assess competence and reliability of external partner(s) and Quality oversight of subcontractors and Third Party Logistics providers (3PLs) to ensure operations comply with regulatory requirements and the conditions specified in the Dossier and in the Quality Agreement.

Professional Education and Skills required:

• Master's Degree in in pharmacy, biology or equivalent;

• Minimum three years of experience in Quality Assurance (GMP/GDP) within the pharmaceutical industry;

• Documented experience with local, european and international GxP regulations would be an asset and is strongly preferred;

• English language - Proficiency at a business level;

• Excellent analytical and problem-solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment; ability to apply sound risk management;

• Teamwork, communication and problem-solving skills.

Required Skills:

Aseptic Manufacturing, Audits Compliance, Communication, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management, Test and Evaluation (T&E), Troubleshooting

Preferred Skills:

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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:

03/25/2026

*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.