Overview - Basic Functions & Responsibility
responsible to implement Quality Operations (Quality Assurance and Quality
Control) policy and discharge all QO responsibilities supporting external parties/partners
and alliances (EP’s) for manufacture, testing, packaging, storage, and
distribution of API intermediates, API, non-sterile pharmaceutical products under
the direction or on behalf of the Executive Director EQA. These activities
include assuring that products are produced from approved processes in
conformance to all applicable regulatory requirements and Company policies and
may include the release of all manufactured products. The incumbent will exercise a leadership role
in monitoring and maintaining the EP’s compliance with the FDC Act, Current
Good Manufacturing Practices Regulations (domestic and foreign), and other
pertinent legal requirements. The incumbent ensures the quality performance of EP’s
through direct oversight, support and technical advice, counselling to the EP
site senior leadership and providing on-site supervision as appropriate. This includes overseeing activities such as EP
selection on a needed basis, GMP Due Diligence, and establishing Quality
Possesses a unique
combination of analytical and scientific skills in order to effectively manage
and control all activities necessary for support of a Quality Operations
program governing for manufacture, testing, packaging, storage, and
distribution of sterile pharmaceutical products, API intermediates, API,
non-sterile pharmaceutical products in conjunction with and under the direction
of the Executive Director EQA. Receives
guidance on policy issues and direction with regard to operations, but
functions independently. Activities
that the Quality Operations department of the EP operates within established
policies and procedures of the Division and Corporation and complies with all
applicable governmental regulations (GMP, etc.), both domestic and foreign.
the development and maintenance of a Quality Agreement with the EP’s. Provides input into the development of
contractual agreements with the EP’s.
a program of calibrated
Quality oversight based on the product type, capabilities, and quality and
compliance performance of the EP.
principal responsibility in oversight of an EP may involve releasing pharmaceutical
products, API intermediates, API, non-sterile pharmaceutical products to other
sites and/or to the market with the assurance that the goods were produced in
conformance to all applicable policies and procedures of Merck and compliance
with all governing regulations. Before
shipment, he/she will assure that products manufactured by the plant have the
correct quality and identity, meet all pertinent specifications and special
requirements, and have been produced by approved processes and under proper
for Quality assurance and control functions to include direct support to EP’s,
coordination and oversight for product testing, as well as other relevant
components as determined by applied calibrated Quality oversight. These components may include review of batch
documentation and deviation investigations.
for maintenance and oversight of ongoing supplier performance management to
include regulatory inspection support and monitoring, internal complaint
management, internal customer feedback coordination, and review of annual
all audit outcomes pertaining to the EP’s and ensures appropriate and timely
corrective actions are identified and implemented.
efforts to improve the EP’s quality and reliability through ongoing oversight
and formal communication programs and forums.
support to the EP’s to facilitate and validate new product introductions. Provides compliance input and support, as
appropriate for implementation of analytical methodology and process
development initiatives. In conjunction
with other internal Merck departments (ACDS-SAS, GPC, EMT), ensures that EP’s
are inspection ready for all new product introductions or transfers.
10. Provides support and develops presentations for
Quality Council meetings. Provides
oversight for presentation content and may support issuance of minutes.
11. Assists in the coordination of significant
investigations including Fact Findings. Assists
in the coordination of product recalls as needed.
12. Operates in a safe and efficient manner and
in compliance with the MMD Q.O. Safety and Health Policy.
13. Conducts quality due diligence assessments
for pre-approval considerations of new EP’s. Supports the EP in remediation of
due diligence and pre-contract audit gaps.
Assures the development and maintenance of a Quality Agreement with the EP. Acts as the Quality expert on Merck's behalf
regarding contractual negotiations and provides input into the development of
commercial contractual agreements with the EP on quality related terms.
14. May act as or support the regulatory
compliance liaison on MSD’s behalf to interface with regulatory agencies.
Closely collaborates with appropriate business and
operations areas to achieve MMD and MSD objectives.
Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)
preferred. Expertise in API (sterile API or Non-sterile API) manufacturing
processes and quality systems. Must have strong knowledge of and broad
experience in Quality Assurance and Quality Control activities. Must have strong demonstrated communication
and relationship building skills. Must
be conversant with all domestic and foreign regulations and compendia governing
plant operations. Some level of
contractual and financial awareness is required.
Job: Qual Assurce - 3rd Party Manuf Job Title:Assoc. Dir, External Quality
Primary Location: APAC-CN-31-Shanghai
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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