GSK Hiring Technologist and Product Owner MS or M. Pharm Apply Now
Key
Responsibilities
Product
Owner
•
Work as a Product Owner with support from Platform Experts to deliver the site
and Technical objectives. For Product Owner at ES India, TRA L1 accreditation
is highly desirable.
•
Product owner shall be a key support to Technical Lead / Manager for driving
technical discussions at PTC.
•
Support operations in the monitoring of the manufacturing process to identify
any issues and optimize / escalate where appropriate.
•
Generate and monitor product quality trends and escalate issues as appropriate
to regional / global Product Owners or Platform Experts. This may involve
leading or participating in a larger scale investigation.
•
Support delivery of Product Lifecycle Management including Technical Risk
Assessments, continuous improvement of Product Control Strategies and
translating Control Strategies into standard work within Operations, as per the
principles of the GSK Production System (GPS).
•
Provides leadership and establishes key relationships within site across
Operations, Technical, Quality and Engineering for the product(s) for which
he/she is accountable, and above site with other Product Owners and R&D.
•
Provides technical input to annual reports, Periodic Product Reviews and
internal and external audits. Product Lifecycle Management
•
Recognized as the principal point of contact for all aspects of current and
previous knowledge on the product(s), performance and end to end process,
including critical quality attributes (CQAs) and critical process parameters
(CPPs). Accountable at site level for maintaining this knowledge and sharing on
site and globally as appropriate.
•
Responsible for ensuring all aspects of Product Quality Lifecycle Management
are in place and actively maintained for the product(s): Technical Risk
Assessment, Product Control Strategy (and translation to standard work as batch
manufacturing instructions as per the principles of GPS), Continued Process
Verification and Process Robustness Assessment.
•
Ensures risks are identified and escalated as appropriate and mitigation plans
are in place and agreed within appropriate quality systems e.g. CAPAs or
governance boards.
Maintains
accountability for the product throughout its lifecycle, influencing the
manufacturing process, analytical process, pack, device, and associated
specifications including technical input to the lifecycle validation approach
for the product.
•
Responsible for assessing the product quality impact of any change (AL1/2/3)
that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment
of the impact of AL2/AL3 primary changes impacting API material properties
(primary product owner), assessment of impact of API/excipient changes on the
dose form (secondary product owner), via the Material Risk Assessment process
(MRA), etc. Other
•
Work within New Product Introduction and ongoing supply to define the technical
requirements for trials and campaigns and liaise with Logistics and Quality
functions to deliver production trials. Assist in the delivery of the technical
requirements for trials, such as batch documents, sample plans, data
collection, tooling, testing regimes, etc. and ensure compliance during trial
manufacture.
•
Support technical aspects of raw material source change by conducting technical
assessments to ensure safe and compliant implementation of change and
continuity/security of supply.
•
Provide troubleshooting support for production processes and equipment's. Carry
out laboratory work as necessary to assist in process improvements /
manufacturing investigations.
•
Provides technical leadership and input into root cause analyses to support the
investigation and resolution of product issues as OOS, complaints and
deviations, in conjunction with ESQ and operations.
•
Support external and internal audits / inspections as required and all relevant
compliance requirements.
•
Provide technical packaging support in response to site LICs & PIRCs,
Quality notifications, CAPAs and internal audit findings, as appropriate.
Why
you?
Basic
Qualifications:
We
are looking for professionals with these required skills to achieve our goals:
MS
(Pharmaceutics) or M. Pharm (Pharmaceutics) with 4-5 years of experience in
pharmaceutical industry
Manufacturing/Filling/Packaging
in the Pharmaceutical/FMCG. Scientific, Technical
To
demonstrate appropriate technical knowledge and training.
TO APPLY CLICK HERE
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