GSK

CommercialQualityExecutive(1yearfixedterm)

Malaysia FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Commercial Quality Executive (1 year fixed term) at GSK. Skills: Quality Management System (QMS), Quality Assurance, GMP/GDP compliance, Regulatory requirements, Continuous Improvement. Maintain effective Quality Management System (QMS). Perform LOC Quality Operation activities”

What You'll Achieve.

Lead and deliver LOC Quality Objectives and Improvement Plan; enhance performance and trust; align on and achieve quality goals; ensure that local operations are in full compliance with GSK standards and policies, GMP, GDP and regulatory requirements; ensure timely reporting, mitigation and escalation of quality risks; ensure all planned changes at the LOC are appropriately managed through change control; Ensure deviations are identified, reported and investigated as per the required timelines; drive on time closure of CAPA implementation; Ensure Quality Alerts that may have potential impact to the LOC operations are timely assessed and CAPA identified; ensure artwork content complies with registration; Accountable in ensuring products supplied to market have the right quality, safety, and efficacy and comply with local regulations; ensure compliance with registration; ensuring the imported products are tested (when required), repacked (where required) and released in a timely manner; ensure the incoming materials, not limited to components and reagents, and medical devices are compliance to the update to date requirements; ensure local repacking (where required) performed by 3rd party repacking service provider complies with GSK standards and local regulations; ensure product storage and distribution performed by 3rd party warehousing and distribution service providers comply with GSK standards and local regulations

Industry & Context.

Problems you'll solve

problem-solving skill; root cause analysis; investigations

Eligibility Requirements

1 year fixed term

What They're Looking For.

Must Have

Degree in Science or related discipline, At least 3 years of relevant working experience in the Pharmaceutical / Consumer Healthcare / Medical Device industries in Quality Assurance role, understanding of and experience in leading quality assurance systems particularly in the areas of batch release, product incidents, artwork control and in the conduct of audits (internal and external), knowledge of regulatory requirements pertaining to GMP/GDP, Good knowledge of effective quality documentation systems

Nice to Have

Background/experience as a Pharmacist., Broad-based knowledge and application of cGMP quality principles, Self-starter and independent, Professional communication – both verbal and written, Analytical mind, good attention to detail and problem-solving skill within a structured process, Ability to engage and work well in cross-functional teams

What You'll Do.

Maintain effective Quality Management System (QMS)

Perform LOC Quality Operation activities

Lead and deliver LOC Quality Objectives and Improvement Plan

Maintain QMS knowledge and monitor commercial changes

Promote a quality-focused culture

Support stakeholders in developing compliant systems

processes and policies

Support the implementation and maintenance of effective Quality Assurance systems

Executing and maintaining a robust

sustainable and effective QMS

Delivering QMS related training

Ensuring quality systems are in place and in use

Quality Document Management

Quality Training support

LOC Quality Council support

Quality Risk Management activities

Change Control impact assessment

Deviation Management and CAPA support/lead

Quality Alerts assessment

Quality Regulatory Intelligence assessment

Inspection and Auditing support

Customer Complaints assessment and reporting

Incident Management investigation support

Artwork Management quality activities

Distribution Risk Assessments (DRA) review

Ensuring products supplied to market have the right quality

and efficacy and comply with local regulations

Coordinate / lead the review of IQA and Quality Agreements

Perform daily quality operations ensuring imported products are tested

repacked and released

Perform quality operations ensuring incoming materials and medical devices are compliance

Ensure local repacking compliance

Ensure product storage and distribution compliance

How You'll Work.

Team & Collaboration

Build collaborative relationships with LOC Supply Chain, LOC Regulatory and Commercial functions; Support stakeholders in developing compliant systems, processes and policies; Work with Regulatory and relevant cross function team to assess the impact on regulatory intelligence; Ability to engage and work well in cross-functional teams

Communication Scope

Professional communication – both verbal and written

Process & Methodology

Lead and deliver LOC Quality Objectives and Improvement Plan, drive continuous improvement, drive on time closure of CAPA implementation

Full Job Description

**Job Purpose** This position is responsible to provide effective and efficient support to the LOC Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations. **Key Responsibilities** 1\. Quality Strategy * Lead and deliver LOC Quality Objectives and Improvement Plan, using KPI trend analysis to drive continuous improvement. * Maintain strong QMS knowledge and monitor commercial changes to identify opportunities and mitigate business risks. * Promote a quality-focused culture across the LOC to enhance performance and trust. * Build collaborative relationships with LOC Supply Chain, LOC Regulatory and Commercial functions to align on and achieve quality goals. * Support stakeholders in developing compliant systems, processes and policies within QMS principles. 2\. Quality Management Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, GMP, GDP and regulatory requirements by supporting the LOC Quality Manager as directed. This includes but is not limited to the following:- * Responsible for executing and maintaining a robust, sustainable and effective QMS (Quality Management System) in LOC that complies with GSK standards and policies, Good Distribution Practice and local regulations, aligned to the LOC applicability matrix * Responsible for delivering QMS related training * Responsible for ensuring the following (but not limited to) quality systems are in place and in use according to GSK QMS standard * QMS Implementation – Completion of assigned gap analysis, implementation to address any gaps identified, develop local procedures (where required), provide relevant training, promote QMS principles and seek continuous improvement of the process. Represent the LOC at relevant forums. * Quality Document Management – maintain an effective docu

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