GlaxoSmithKline Quality Executive - Pharma Business Jobs in Nairobi Kenya
GlaxoSmithKline Quality Executive - Pharma Business Jobs in Nairobi Kenya
Job Purpose :Provides effective and efficient quality assurance systems support to the LOC Quality Manager, 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.
Key Accountabilities / Responsibilities
Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans at a high as they potentially link to day to day and quality improvement activities.
Supporting the LOC Quality Manager to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC element of the Supply Chain and (GlaxoSmithKline East Africa) Marketing Company.
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 to:
Ensure that all SOPs are in place, updated & training has been conducted across the business. 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.
Promote QMS management principles and seek continuous improvement of the processes
Review, conduct impact assessments and implement any updates to QMS policies
Manage QMS Management Review meetings according to local SOPs
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 re organizing Council meeting with regular meetings.
This support should ensure that the LOC Quality Council format, frequency and reporting are standardised to global requirements.
In addition support should be provided re Quality metrics and reporting format/ system in place.
Change Control - perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.
Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s.
Local process in place to track and review CAPA plans on routine basis. Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
Auditing - perform day to day work to support the local process that is in place
for Level 1 (self-inspection) and Level 2 monitoring auditing. Work with the LOC Quality Manager to ensure the Level 1 and Level 2 auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management.
Level 1 and Level 2 audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
There is a process in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by either LOC QA Team or the appropriate Central Team (e.g. ESA). e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers. LOC element of the Supply Chain and the Quality elements of the Marketing Company are audit ready for any relevant Level 3 or 4 audits.
Complaints - perform day to day work to support an effective complaints management process ensuring the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate.report and follow up on product complaints with manufacturing sites, customers and commercial teams.
Incident management – Support the LOC Quality Manager to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global PIRC process.
Assist the LOC Quality Manager in any investigations triggered by local incidents and in conducting LOC Incident Committees.
Basic qualifications:
Successful completion of relevant tertiary qualifications – Science Degree
Minimum of 2 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
Knowledge of regulatory requirements pertaining to GMP/GDP
Knowledge of effective quality documentation systems
Essential Skills and Abilities:
Ability to deliver clear communications and foster excellent working relationships with peers and management
Analytical mind, good attention to detail and problem solving skills within a structured process
Good team player – works well in cross-functional teams
Ability to multi-task and work under pressure
Concise in the description of the different QA situations. Able to stick to the standard and not be pressurized.
Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
Flexible thinking – able to challenge and see views from different perspectives
Ability to self-motivate and be resilient and focused under pressure
Preferred qualifications:
Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
How to Apply
Interested and qualified candidates should apply online by 17th July 2019
For more information and job application details, see; GlaxoSmithKline Quality Executive - Pharma Business Jobs in Nairobi Kenya
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