We are looking for a Specialist, Quality Assurance to provide direct support to the local Quality Responsible Person in the management of the day to day aspects of the Quality Department.
The role includes responsibilities for implementing procedures and best practices supporting our affiliate. The incumbent will interact with global and local stakeholders, maintaining compliance with worldwide regulatory requirements, current Good Distribution Practices (cGDPs), Quality Manual, and pertinent legal and / or business requirements.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
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)
Information and interaction with local business and regional Quality Management
Ensure Quality perspective is brought into local business initiatives with Quality impact
Local coordination and execution of recalls
Primary country contact for Quality
Primary country contact for HA issues pertaining to Quality and Supply issues
Develop, implement and maintain the local Quality Management Systems (procedures)
Applying Quality Risk Management (QRM) principles
Development and maintenance of local Quality training program
Ensure Quality training of personnel including assessment of training effectiveness
Complete trainings as required for role
Development and keeping of records for any delegated duties
Ensure quality and accuracy of documentation and records retention
Approve and review local procedures with Quality impact
Ensure effective management of Product Quality Complaints (PQCs) including routing the PQCs and samples to the manufacturing site (including Morocco, FWA and Tunisia)
Tracking, trending or signaling of PQCs (including Morocco, FWA and Tunisia)
Handling of PQC customer responses (including Morocco, FWA and Tunisia)
Management and / or review of Product Quality Reviews (PQRs)
Coordination of Customer Temperature excursion assessment
Deviation management, overview and tracking
Management of CAPAs, including tracking
Ensure handling of temperature excursions during transport, warehousing and distribution
Handling of customer communications
Ensure Change Control procedure is applied
Ensure only validated IT-systems are used in the GxP area
Establish and maintain local overview of used IT-systems with Quality-impact
Participate or ensure due diligence and audits to assess competence and reliability of external partner(s)
Review and approve Quality Agreements to ensure inclusion of appropriate Quality elements
Quality oversight of subcontractors and Third Party Logistics provider (3PL) to ensure operations complies with regulatory requirements and the conditions specified in the Dossier
Individual batch release or certification at importation in country
Manage representative batch release samples in line with national legislation
Participate in the process of importation of non-registered product in country
Control of incoming goods arrangements
Ensure or Monitor accuracy of delivery documentation (e.g. Batch Release Certificates)
Supply Issue Management including HA notifications
Interaction with company Supply Chain
Manage HA exemption requests (e.g. to allow distribution of product intended for another market, i.e. labeled in another language to minimize patient impact in stock-outs)
Ensure correct storage conditions are applied and monitored at 3PL level
Returned Goods Management
Approve deviations from First Expiry First Out (FEFO) principles;
Issue or respond to Administrative Holds (Quarantine Management)
Local Destruction oversight
Ensure adherence to product storage conditions and special conditions
Ensure qualified equipment and packaging is used for temperature-sensitive products
Ensure handling of complaints related to distribution
Management of repackaging / re-stickering activities
Ensure preparation of Quality Metrics (e.g. deviations, inspection outcomes, PQCs, CAPAs)
Present Quality Metrics to stakeholders (e.g. management, Quality Compliance Council)
Oversee and Track Quality Improvement Actions
Self-Inspection planning, execution and documentation
Act as a Designated Point of Contact (DPOC) for intake and triage of safety, quality and medical inquiries
Review and approve Quality documentation for all incoming goods (CoA and temperature records)
Local Destruction oversight
Review and Approve Quality Documentation related with re-stickering activities
Ensure preparation of Quality Metrics
Participate in Quality System Review
Higher education (e.g. Master’s degree) in pharmacy or biology
Minimum of 2 years’ experience in Quality (GMP / GDP) within Pharma industry;
Knowledge of quality related pharmaceutical local regulations;
Technical and Scientific Knowledge;
Quality Management System principles
Fluency in French and English is essential
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who We Are
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as Merck in the United States, Canada & Puerto Rico. We are known as MSD in Europe, Middle East, Africa, Latin America & Asia Pacific.
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers.
We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What We Look For
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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.
We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
Temporary (Fixed Term)
No Travel Required
Flexible Work Arrangements
Valid Driving License
Number of Openings
Requisition ID R59032