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EQA - Product Quality Manager API Job

Date: Oct 27, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: QUA006332

MSD
is a global healthcare leader with a diversified portfolio of prescription
medicines, vaccines and animal health products. Today, we are building a new
kind of healthcare company – one that is ready to help create a healthier
future for all of us. 



Our ability to excel depends on the integrity, knowledge, imagination, skill,
diversity and teamwork of an individual like you. To this end, we strive to
create an environment of mutual respect, encouragement and teamwork. As part of
our global team, you’ll have the opportunity to collaborate with talented and
dedicated colleagues while developing and expanding your career.



 


We look for a strong candidate who will foster
strong partner relationships with our External CMO partners specifically for
APIs. The role could be based anywhere in Europe or North America close to one
of our manufacturing sites.



You would be joining at an interesting time at
MSD – we are in the midst of positive change moving
our systems, processes and culture in a more coordinated direction. We seek to
encourage the business to become more proactively risk focused, secure a more
stable supply base from API suppliers (potentially shifting to new vendors) and
support the enablement of new launch products getting to market with robust new
API vendors.



Overview



The Product Quality Manager
is responsible for ensuring that all Merck/MSD products managed by External
Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored,
and distributed in accordance with Merck/MSD expectations and all applicable
regulatory requirements. 



Incumbent will have
responsibility for External Party / External Partner (EP/ExP) operations
related to the quality of products produced, under the oversight and guidance
of the External Site Quality Lead – EQA. 
Role has primary batch release responsibility.  Incumbent will ensure that effective and
robust Quality systems are in place to comply with required regulations,
policies and guidelines governing the EP/ExP’s manufacture and release of (API intermediates, API) by means of
risk-based quality oversight and on-site supervision, as appropriate. 



 


Primary Activities include, but are not limited to the following:


  • Evaluate and/or release
    products to other sites and/or to the market with the assurance that the goods
    were produced in conformance to all applicable policies/procedures of MSD
    and compliance with all governing regulations; review and approve changes to
    master batch records
  • Manage routine deviations
    and complaints, and assist in the coordination of significant investigations
    including Fact Findings; assist in the coordination of any product recall
    involving the external manufacturer
  • Provide guidance to the
    partner on conducting investigations of batch rejection, atypical events,
    customer complaints, etc. where warranted
  • Provide support for audits
    of EP/ExP by MSD and regulatory agencies; review audit outcomes
    pertaining to external manufacturers and ensure appropriate and timely
    corrective actions are warranted
  • Conduct routine analytical
    change requests and support process modification change controls
  • Stability Program
    management, including review of stability reports, and Annual Product Review
    assembly
  • Provide on-site guidance in
    the preparation of metrics, procedures, and guidelines; provide proactive
    support in training and coaching to initiate quality improvements
  • Provide support in establishing
    a program of calibrated Quality oversight based on the product type,
    capabilities, and quality and compliance performance of the external
    party/partner
  • Track and monitor
    operational and quality performance of the external manufacturer/partner
  • Assist the maintenance of
    retention samples, ship reagents and samples to support licensure and foreign
    registration; responsible for shipment under quarantine
  • Support routine process
    validation;  review and approve
    validation reports/tech transfer
  • Support document requests
    for regulatory filings and post approval changes
  • Gap remediation plans,
    Quality Risk Management data inputs,  and
    data integrity gap assessments
  • Receive and share Quality
    Alerts and Quality Bulletins with EP/ExP
  • Regular site visits to
    build relationships and monitor efforts to improve the external manufacturer’s
    quality and reliability through ongoing oversight and formal communication
    programs and forums
  • Closely collaborate with
    appropriate business/operations and technical areas to achieve MMD and MSD objectives
  • Demonstrate and promote EHS
    leadership behavior, ensuring that all MSD site activities are carried out in
    accordance with SHE requirements.
  • Ensure both operational
    knowledge and technical skills are maintained and compliant against individual
    training requirements


 
Qualifications

Qualifications


  • BSc
    Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or
    equivalent) preferred.


 Typical Minimum Experience:


  • Minimum
    of 5 years’ experience in the pharmaceutical industry with a thorough
    knowledge of Quality Systems, Quality Assurance and Quality Control
    including solid knowledge of global GMP and regulatory requirements.


Professional / Behavioral Skills:


  • Ability
    to work across boundaries
  • Strong
    problem-solving skills
  • Effective
    written and oral communication skills
  • Proactive
    and self-motivated, well developed organizational skills with ability to
    multitask
  • Strong
    interpersonal and relationship building skills; effective negotiation and
    influence skills
  • Demonstrated
    Merck Leadership skills (e.g., Drive Results, Focus on Customers and
    patients, Make Rapid, Disciplined Decisions, Act with Courage and Candor)


Technical Skills:


  • Possess
    a combination of analytical/scientific skills in order to effectively
    manage and control all activities necessary to support a total Quality
    Operations program governing external parties/partners that manufacture,
    package, analyze, release, store and/or distribute MSD product. 
  • Thorough
    knowledge of all aspects of EM management, supply chain, and operations
  • A
    broad knowledge of manufacturing operations, including engineering,
    materials, R&D, production, etc.
  • Lean
    Six Sigma




Job: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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