Senior Specialist, Quality Assurance

Job Description

Job Purpose

The Senior Specialist, Quality Assurance will take the role of Pharmacist in Charge and provide quality oversight for the newly established Middle East & Africa (MEA) Regional Distribution Center in the United Arab Emirates. The role is responsible for ensuring compliance with Good Distribution Practices (GDP), local regulatory requirements, and our Company´s  Quality standards related to storage, transportation, handling, and distribution of pharmaceutical products.

Key responsibilities:

• Ensures compliance with GDP and local regulatory requirements for transportation (in- and outbound activities), storage and product handling.
• Ensures that third-party logistics (3PL) provider complies with GDP and local regulatory requirements and aligns with Quality Agreement. Monitors all tasks delegated to 3PL and listed in this Agreement and takes action if notices any non-compliance or gap.
• Collaborates with and supports the relevant QRP, regional Quality Management, supply chain functions and other internal departments of our Company on quality matters and makes notifications as required.
• External communication and collaboration:
  • Communicates with the competent Health Authority in UAE.
  • Communicates with service providers and subcontractors.
  • Communicates with and supports representatives of target markets/target countries.
  • Communicates with Marketing Authorization Holders.
  • Manages and participates in audits/inspections, recalls.
  • Writes, approves & reviews procedures with GDP impact.
  • Performs self-inspection and deviation investigation.
  • Manages, documents and monitors deviation, CAPA, change control, risk assessment.
  • Ensures facility, equipment, system validation is performed, and results meet requirements.
  • Reviews and approves contracts that concern quality assurance.
  • Maintains the Document Management System.
  • Applies principles of Quality Risk Management.
  • Handles the complaints reported from the markets supplied and in accordance with Manufacturing Division complaint handling process.
  • Assesses temperature excursions.
  • Manages and documents all relevant tasks with GDP impact.
  • Management Review and Quality Metrics.

• The responsibilities above also include authority to issue instructions, act and take decisions to fulfill HA requirements and to safeguard patient health. The responsible person must always make decisions based on their own evaluation and the information they have acquired.

Education & Licensing Requirements

• University degree in Pharmacy.
• Licensed Pharmacist in the United Arab Emirates. Pharmacist license may be issued by:
  • Ministry of Health and Prevention (MOHAP), under a federal pharmacist license; or
  • A local health authority, including: Dubai Health Authority (DHA) or Department of Health Abu Dhabi (DoH Abu Dhabi).
• The candidate must be eligible to serve as the designated Pharmacist in Charge in accordance with applicable UAE regulatory requirements.
• Experience in pharmaceutical wholesale and quality assurance preferably.
• Good knowledge of wholesale and distribution operations.
• English and Arabic communication skills (both spoken and written).

Required Skills:

Preferred Skills:

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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