GlaxoSmithKline Pakistan Job Karachi, Quality Manager
Basic Qualifications: Pharm-D or Applied Chemistry
1. Quality Strategy:
– Key market contact and responsible person for all QMS activity and issues, relating to the commercial business and work closely with the Quality Head MENA to develop and implement Quality strategy across the area.
– Assess and proactively create and implement a continuous improvement plan for the adoption of the principles and requirements of a Quality Management System into the commercial business, includes identifying, understanding and sharing appropriate information.
– Heighten and promote quality and QMS awareness in the commercial business functions.
– Engage and assist relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business, in compliance with QMS principles.
– Build strong relationships across the LOC Commercial Business functions and work with them to develop quality objectives that meet both business and regional quality objectives. Undertake relevant training forums to deliver QMS knowledge to relevant parts of the business enabling them to identify, incorporate and deliver on relevant quality objectives.
– Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
– Develop a network to obtain local regulatory intelligence and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation.
– Act as the relevant LOC quality contact for the Regional Quality organisation providing communication to the regional quality organisation on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning’s and issues appropriately with other LOC and regional colleagues.
– Gain understanding of the high level business plans of the LOC as they potentially link to quality – ensure any quality activities are identified and defined in the annual quality plan.
2. Quality Systems:
– Responsible for the ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the Pakistan Cx LOC.
– Implement and maintain 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 performing the following:
– 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, 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
– 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 in place with regular meetings and including all relevant business functions. LOC Quality Council format, frequency and reporting standardised to global requirements. Quality metrics and reporting format/ system in place with oversight and review during LOC Quality Council
– Change Control – Effective local change control process in place to manage all planned major changes (including new pack introduction, product discontinuation, major pack changes, re-packing activities). Change control process links to risk management process and risk assessments completed. Processes in place to routinely review progress of changes and close out when completed.
– Risk Management – Local risk management process in place across business with common review and escalation process. Local process in place to manage, report, review and escalate quality risks. Quality should be linked to the local Risk Management Board.
– 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 – Local process in place for Level 1 (self) and Level 2 auditing – includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management. Level 1 and Level 2 audit universe defined and agreed with Regional Quality and annual audit schedules in place. Processes 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 QA team according to agreed audit schedule. e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers. Ensure LOC is audit ready for any relevant Level 3 or 4 audit.
– Complaints – Effective complaints management process in place with monthly reporting to consider trends and identify improvement opportunities. Complaints management process should also have clear link to adverse event reporting and be able to determine product quality issues as quickly as possible and link into local product incident process. Report and follow up on product complaints with manufacturing sites, customers and commercial teams.
– Incident management – Effective local product incident process in place to escalate and manage any product quality related issues. Must be well documented process and link into Quality Council as well as into above country PIRC process. All relevant staff trained in local incident management process and global PIRC process.
Product Supply – Develop, specify and approve systems that have an impact on the quality of imported, products in line with all relevant GQPs:
– Accountable for review and approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.
– Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details.
– Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
– Acts as the primary liaison with the GMS supplying sites, R&D and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied
– Artwork management – Oversee the effective implementation of Artwork Management procedures within the LOC.
– Oversee the effective implementation of Artwork Management procedures within the commercial teams
– Ensure that the commercial business units can effectively use the global pack management systems (GPM) for Artwork Management by acting as business deployment lead to relay GPM requirements and also to feedback the market needs to GPM
– Local Repacking – Manage all matters pertaining to regulatory and QA compliance for repacking procedures to ensure timely QA batch release of repacked orders before distribution and/or re-export. Ensure documentation of batch records and retention of samples.
– Training – Engage with LOC to identify training needs and work together to address these.Monitor the Training matrix and progress for the compliance. Conduct relevant training to the LOC’s to develop in-market capability and skills
3. Management of quality team in LOC:
– Manage and co-ordinate day to day quality department activities including resource allocation, workflow, project priorities and department initiatives.
– Manages and develops quality staff within LOC team to drive a quality culture within the LOC.