Associate Quality Specialist Job

Date: Mar 22, 2019

Location: Singapore, SG

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Requisition ID: QUA008349

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Key Responsibilities

- Ensures accurate, consistent and timely entry of product complaints related details into electronic tracking system.
- Interfaces with site investigation unites (SIU) to ensure receipt of information, address follow-up questions and closure of complaints.
- Interfaces to Designated point of contact (DPOC) to ensure accuracy of information, provide assistance with sample retrieval and assure customers responses are provided as required.
- Manages intake of complaint samples for Asia Pacific region, identifies appropriate investigating sites documents sample information and prepares sample for shipment to investigating sites.
- Performs functioning testing’s when designated by SIU documenting all findings in the complaint records.
- Develop operating procedures for areas to ensure consistent processes amongst team.
- To independently solve problems that arises within job responsibilities and expectations.
- Develop and oversee plans for all activities related to local / regional projects including connections to products recalls and clinical stocks recoveries.
- Maintain appropriate oversight of SOPs for complaint management activities.
- Participate in continuous improvement initiative, EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
- Perform any other tasks as assigned by manager

Deviation/OOS/Customer Complaints

Participates in investigations, reviews and approves investigation reports.
Tracks Corrective Actions/Preventive Actions and ensures timely completion.
Generates deviation summary reports.
Performs trend analysis of root causes on a periodic basis.
Reviews and closes completed OOS.
Qualifications

Bachelor’s Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
Have a basic understanding of Lean
Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirement
1 - 3 years of relevant experience in quality assurance in pharmaceutical manufacturing environment,  supplying  to  highly regulated markets such as FDA and EMA

How to Apply? 

Interested candidates can submit their application online through MSD Career site. If you need further information, you can email Cai E Neo at cai.e.neo@merck.com or Isabel Petallar maria.isabel.m.petallar@merck.com. 

What we offer at MSD? 

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

Search Firm Representatives, Please Read Carefully:  

MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means


Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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