Specialist, Supplier Quality Assurance

Specialist, Supplier Quality Assurance
Empresa:

Merck Gruppe - Msd Sharp & Dohme



Área:

Otros

Specialist, Supplier Quality Assurance

Detalles de la oferta

We are one company, Merck & Co., Inc., Kenilworth, New Jersey, USA but we operate under two different corporate brand names. We are known as Merck & Co., in the United States, Canada & Puerto Rico. We are known as MSD outside the United States, Canada & Puerto Rico.
This site is for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific.
Residents of the United States, Canada & Puerto Rico, please click here .

Job Description
Position Description
The primary purpose of the position is to support External Quality business processes. This includes:
Providing support to the audit program manager for the oversight of the supplier audit program including schedule creation, schedule updates and accuracy of data.
Manage data entries into the quality electronic audit systems including those for MMD sites and those for external suppliers.
Scheduling and oversight of contractors used to perform audits. Perform audit report and CAPA review and entry into audit management systems
Creating, tracking and reporting of compliance metrics and status of quality issues
Performing audits as assigned.

Responsibilities
Reports to and receives guidance from the Supplier Quality Assurance (SQA) Audit Program Manager. Keeps the audit program Manager informed on the status of operations and when challenges, opportunities and/or issues arise.
Performs internal management, oversight and tracking of the MMD supplier audit program in support of, and as assigned by the audit program manager.
Performs accurate and complete data entries into the supplier and MMD site audit systems
Ensures compliance to auditing procedures
Creates, tracks and presents metrics used to monitor the audit program
Manages the use of contractors to perform supplier audits including reviews, approvals, and entry into External Quality and MMD systems.
Supports the action indicated process for critical observations and audit refusals
Maintain the accuracy of the audit schedule and perform routine schedule updates

Supports supplier qualification and change control as needed for firms in SQA scope.
Creates, tracks and presents metrics used to monitor quality processes within External Quality as assigned (deviations, change controls, regulatory inspection notification and tracking, new and ongoing quality initiatives etc.)
Performs audits as assigned
Completes additional Quality related activities as required to fulfil the role.
Education Minimum Requirement:
Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)

Required Experience and Skills:
Must have expertise and experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of GMP and regulatory requirements
Must have the ability to manage multiple activities concurrently and have strong organizational skills with attention to details.
Must have proficiency in collecting, analysing and concise reporting of data and relevant conclusions.

Preferred Experience and Skills:
Auditing experience and training
Previous experience in a business process support role

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 continueInventing For Life, Impacting LiveswhileInspiring Your Career Growth.
INVENT.
IMPACT.
INSPIRE.
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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
10%Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R58752
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Your Name
About UsWe are one company, Merck & Co., Inc., Kenilworth, New Jersey, USA but we operate under two different corporate brand names.

We are known as Merck & Co., in the United States, Canada & Puerto Rico. We are known as MSD outside the United States, Canada, & Puerto Rico.
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This careers website is intended for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific.
Residents in the United States, Canada & Puerto Rico, please visit this Careers website .
Information on this site is for the purpose of presenting career opportunities at our organisation and give our audience a view of our culture, diversity and growth opportunities.
Our Company is an equal opportunity employer, proudly embracing diversity in all of its manifestations.
This website is maintained by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


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