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| GSK - Dubai |
Posted Date: May 16 2021
Job Purpose:
The LOC Quality Executive roles exists to provide effective and efficient quality assurance systems support to the LOC Quality Manager or LOC Quality Area Lead, including supporting the implementation and maintenance of the QMS and as directed by the LOC Quality Manager . performs the day to day work to ensure that the quality systems required by the LOC element of the Supply Chain and Marketing Company LOC are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator.
The LOC Quality Executive will act as Quality Representative within the Commercial Team supporting the delivery of quality management system for the nominated area or country. The role holder will also partner with the business to ensure that their business requirements are understood.
The role will take supporting role to drive a quality culture within the LOC.
The role will drive standardized business processes where applicable across LOC to maximize business benefits.
Key Responsibilities:
- Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity. providing communication to the regional quality organization on progress on QMS Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements by supporting the LOC Quality Manager as directed
- Ensure that all SOPs are in place, updated & training has been conducted across the GxP business processes. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant.
- Identify, Implement and Manage QA Objectives & KPIs
- Establish and manage Annual Quality Plans.
- Support the LOC Quality Manager to ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to)
- LOC Quality Council – support the LOC Quality Manager in organizing Council meeting to ensure that the LOC Quality Council format, frequency and reporting are standardized to global requirements.
- Change Control - perform day to day work to support the local change control process
- Risk Management - support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
- Deviation Management, RCA including Human Factor Analysis: implement effective RCA tools to effectively identify root causes.
- Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans
- Auditing - perform day to day work to ensure the local process are in place for the 4 Audit levels and as well to effectively support Third party audits and follow up.
- Complaints - perform day to day work to support an effective complaints management process.
- Incident management – Support the LOC Quality Manager to ensure that an effective local product incident process and global PIRC process are in place to escalate and manage any product quality related issues
- Product supply - performs day to day work to support systems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements
- Artwork process oversight - perform AW KPIs improvement in line with the roles and responsibilities for quality as defined in the artwork procedures.
- Local Repacking –support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export.
- Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with GSK policies.
- Ensures all product specifications and related documents (e.g. CoAs, TTs) are maintained compliant to current registered details.
- Maintains and updates the QA Standard Operating Procedures
Knowledge/ Education / Previous Experience Required:
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Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
- University Degree in a Science or related discipline (Chemistry, Pharmacy, Biology…).
- Minimum 5 years’ experience within pharmaceutical industry and application of Quality Systems.
- High demonstrated level of GMP/GDP knowledge.
- Exceptional leadership skills.
- Excellent oral and written communication skills.
- Proven influence and impact skills across business levels and functions.
- Strong interpersonal and negotiation skills.
- Problem identification and solving skills.
- Ability to enable and drive change.
- Excellent command in English language both written and verbal .
- Self-starter, able to schedule and progress workload on own
- Experience of working with and leading cross-site and multi-functional team.
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Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
