This role offers an opportunity to contribute within a leading global biopharmaceutical manufacturing environment, focused on the production and supply of innovative human therapeutics. The facility specializes in aseptic drug product operations, including
formulation, vial/syringe filling, lyophilisation, and packaging
, supported by on-site laboratories and cold-chain warehousing capabilities.
The
Quality Assurance Technical Support (QA TS) Specialist
is a key position within the site Quality Assurance function and reports to a QA Manager. The successful candidate will act as a
Subject Matter Expert (SME)
within assigned areas, providing quality oversight and ensuring compliance with regulatory and corporate expectations.
Key Responsibilities
* Provide overall
quality direction and oversight
for key functional areas such as
inspection, validation, quality control, and engineering
, ensuring that all programs, policies, and procedures are compliant, effective, and aligned with regulatory requirements.
* Perform
quality review and approval of validation documentation and SOPs
, supporting site validation activities, including:
* Review of design specifications (DS) and quality risk assessments (QRAEs)
* Review and approval of validation plans, protocols (IQ/OQ/PQ), and associated documents
* Assessment and approval of executed validation reports
* Provide
QA oversight of change controls, deviations, and CAPAs
, ensuring appropriate scope definition, robust implementation, and timely closure.
* Participate in
Change Control and Deviation Review Boards
to provide quality input and decision-making support.
* Support a
safe and compliant working environment
, adhering to all environmental, health, and safety standards and procedures.
* Perform all activities in compliance with applicable safety, quality, and regulatory standards.
* Contribute to continuous improvement initiatives and process optimization projects within QA and cross-functional teams.
Preferred Qualifications
* Bachelor's degree in a
Science or Engineering discipline
(advanced degree preferred).
* Minimum
7 years of experience
in the
pharmaceutical or biotechnology industry
, ideally providing quality oversight across key functional areas such as packaging, inspection, validation, quality control, engineering, or information systems.
* Strong understanding of
validation principles
and
new product introduction (NPI)
processes.
* Proven experience managing
change control
,
non-conformance
,
CAPA
, and
validation activities
within a GMP environment.
* Ability to work effectively
across cross-functional boundaries
, both internally and externally.
* Strong
critical thinking
,
communication
, and
organizational
skills.
* Self-motivated and capable of operating independently with minimal supervision.
* Skilled in
facilitation
,
coordination
, and
collaborative problem solving
.
* Team-oriented professional who thrives in a
collaborative, decision-driven culture
.