Job Purpose Statement
The role is meant to lead assurance activity within the CHQSC site, Nairobi and to ensure all Processes are initially qualified and subsequently maintained in a qualified state as per the Quality and Compliance standards required by GSK and other major regulatory bodies. The role is meant to ensure site technical capability is appropriate to maximize the efficiency of the operations and ensure that manufacturing processes are capable and controlled through PUCC, Validation and Technical risk assessment (TRA) so that each unit meets the product quality standards both at the time of manufacture and throughout its shelf life.
The role is accountable for :-
- Co-ordination and implementation of product validation schedules on LVS in accordance with the QMS.
- Support/Lead Technical Risk Assessment for LVS products. Support development and approval of Product Control in LVS.
- Implementation Process Change Control processes in accordance with the QMS
- Co-ordinate & implement Data Trending process across all VS
- Co-ordination of Periodic Process Reviews for product on LVS in accordance with the QMS
- Development / maintenance of relevant Technical reporting systems & databases
- Supporting Operational Excellence initiatives.
- Drive Technical and continuous improvement initiatives across GSK Likoni Road site and integrate Technical standards into site business plans and activities.
- Identify training needs of Technical Process Specialists supporting LVS products and ensure training plans are put in place to address these needs.
- Manage the Technical Process Team and provide ongoing support to all the value streams in relation to manufacturing process issues.
- Co-ordination of the Process Prioritisation listing to ensure the most appropriate use of both technical/ financial resource is being deployed.
- Support the site Problem Solving Process.
- Attendance at key site plant meetings
- Co-ordinate the weekly Process Technical Team Meetings
- Support the site monthly Technical Review meeting.
- In conjunction with NPI Technical manager Support the site procurement initiatives in accordance with the QMS.
Essential Job Responsibilities
Fundamentals (Safety, Quality, people and Process)
Perform duties in a compliant manner and behave in accordance with GMP, Site SOP’s, GSK EHS and QMS Standards and guidelines and relevant legal requirements.
- Read and understand Standard Operations procedures and Global Quality applicable to Role.
- Report all accidents, incidents and any EHS issues using the appropriate process/ System to your manager, or if required the Occupational Health Advisor.
- Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards, be aware of the impact of your job activities on EHS issues.
- Ensure all changes made have safety considerations and best practise as core attributes.
- Management Policies relevant to your job role Attend training and complete assessments as required Ensure Quality and GMP are at the forefront of changes proposed.
Innovate the Business
Identify Product development opportunities (for existing and new innovations) for the Value stream.
- Manage source changes for materials affecting the Support value stream
- Manage product development, New product introduction and source changes in the value stream through process validation, analytical methods and Technical product transfers thus reducing quality and technical risks
- Drive and implement product life cycle management (PLM) in the support value stream.
- Ensure QMS Compliance through GMP training, quality auditing, gap analysis and CAPA management
- Pro-active approach to the process defects through process understanding, capability and control (PUCC)
- Support and drive the waste and cost reductions in the business through value engineering projects, defects management and systems assurance. Work with procurement department to support the PPV initiatives.
- Ensure changes with potential impact on product quality and/or other QMS/GMP compliance requirements are appropriately assessed before implementation through the site change control process.
Create and manage measurement systems to track adoption/progress, utilization and proficiency of key business value drivers
Strategic Alignment & Sustainability
▪ Work with the site Process Assurance and Validation Lead to ensure financial discipline on Budgeting and spend for the proposed initiatives.
▪ Develop constructive and beneficial working relationships across the Site Leadership Team, the local GSK business unit, the regional CHQSC organization and appropriate external stakeholders including suppliers and regulatory bodies
▪ Generates batch process documentation on new product introduction and routine review to facilitate smooth production flow, supports and provide technical advice to Quality and other functions as required for them to make product and process decisions.
▪ Provides suitable and adequate technical training to raise staff competency levels to ensure manufacturing processes in control and audit ready at all times. Manages the samples and documentation retention as per the policy requirements
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