EMAIL: (Please contact us using the "Apply for this Job Posting" box
below)
_OVERVIEW:_
The External QUALITY Specialist is responsible for ensuring that
all products managed by External Quality Assurance (EQA) are
manufactured, packaged, analyzed, released, stored, and distributed in
accordance with client 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 Product Quality
Manager 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.
_QUALIFICATIONS: _
* 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.
_PREFERRED COMPETENCIES AND SKILLS:_
* Experience in SAP and Trackwise
* 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 / Merck Production Systems training
PHONE: +**Apply on the website** **Apply on the website**
EMAIL: (Please contact us using the "Apply for this Job Posting" box
below)
_OVERVIEW:_
The External QUALITY Specialist is responsible for ensuring that
all products managed by External Quality Assurance (EQA) are
manufactured, packaged, analyzed, released, stored, and distributed in
accordance with client 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 Product Quality
Manager 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.
_QUALIFICATIONS: _
* 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.
_PREFERRED COMPETENCIES AND SKILLS:_
* Experience in SAP and Trackwise
* 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 / Merck Production Systems training
We need : English (Good)
Type: Permanent
Payment:
Category: Others
