Quality Assistant at Sheer Logic

Key Responsibilities;

Quality Strategy

• 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 GSK Kenya Quality Plans
• Seek a great understanding of commercial Quality Assurance work in a pharmaceutical setup

Quality Systems

• Supporting Quality head 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, ensure compliance to Good distribution practices (GDP) and related regulatory requirements

Product supply – (Support commercial ambition on product supply)

• Performs day to day work to ensure continuous, flawless, quick, and timely product release to the market in line with GSK QMS policies to avoid any out-of-stock situation
• Work closely with GSK Supply chain and distribution teams to ensure that product supply is not impacted by prioritizing all activities related to product availability
• Work closely with the supply sites quality team to resolve any product quality incidences in a timely manner to avoid market out of a stock situation
• Work closely with the market regulatory team to gain an understanding of product registration details/ compliance and supply requirements
• Build a close working relationship with the warehouse team, including but not limited Warehouse Quality team, operations, and customer-care teams
• Support market distributors in resolving any issues to do with product incidences and queries in a compliant manner

Quality Management systems Implementation

• The successful candidate will be required to support GSK Quality Management systems implementation in different roles, including but not limited to the following
• Policies/ Procedure implementation – Follow global and local requirements to ensure that GSK policies and procedures are implemented as per global implementation guidelines
• Auditing – perform day to day work to support the local process that is in place for GSK self-inspection and internal audit process as directed by the audit process owner
• Corrective and Preventative Actions (CAPA) – Support the Quality head in implementing global processes to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s. system process in place to track and review CAPA plans on a routine basis. Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored, and closed out.
• QMS review committee (Quality Council) – support Quality head in organizing Quality Council meetings, meeting preparation, taking of minutes, action implementation and keeping of records
• Product Quality Management -Support product quality (GSK trust agenda)

Complaints –

• perform day to day work to support an effective complaints management process ensuring
• that assessment of potential issues is determined 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.
• Track product complaints management process, ensure investigations results are communicated to the concerned customers in a timely manner

Incident management –

• Support Quality Head to ensure that an effective local product incident management process is in place
• receive concerns of suspect packs and queries from the market (mostly through the sales team) work with GSK relevant teams to identify any possible counterfeits and escalate as required
• participate in product incident investigations, keep records and minutes as required
• Assist Quality Head in investigations on products concerns and queries from the Market

Education and Experience:

• Bachelor’s degree – preferably a science degree from a reputable institution
• Minimum of 3 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 on effective quality documentation systems