Job Purpose
To ensure business compliance with the relevant regulations as the Responsible Pharmacist is accountable for the operational requirements of the company, Personnel, and Infrastructure, within the framework of Good Pharmacy Practice (GPP), Good Distribution Practice (GDP) and Good Wholesaling Practice (GWP) and takes responsibility in terms of relevant Act.
Job Function:
Qualified person for Pharmacovigilance- Ensuring adherence to local regulations, providing prompt information to regulatory authority requests, and providing 24 hours availability.
Products quality compliance operations- logical flow of product, segregation of functional areas where applicable (Inbound, Outbound, Reverse logistics, Rejects, Quarantine, High Risk, Narcotics)
Standards of operating procedures- Review QMS Index. Identify business processes (SOP’s, Work Instructions and Forms) that requires review and ensure review is completed within the approved timeframe and in line within country regulations.
Non- conformances- Initiate / ensure that non-Conformances are initiated, reviewed, and evaluated.
Management and control – Establish systems for effective control of regulatory compliance in line with PPB requirements.
Implement systems for effective control of regulatory compliance.
Audits and CAPAs – Plan and conduct internal audits in conjunction with QA (MS), according to required Standards (PPB / GWP / ISO 9001:2008) and client requirements.
Critical system implementation and changes
Product registration- Ensure that client products are registered and retained as per the PPB regulations and other Regulatory bodies within the region.
Responsibility in terms of the relevant Act
Facilities – logical flow of product, segregation of functional areas where applicable (Inbound, Outbound, Reverse logistics, Rejects, Quarantine, High Risk, Narcotics)
Verification and approval of Customer accounts and vendors (Legal status)
Material Master: Review and approval.
Environmental control and monitoring – daily, weekly, and monthly of ambient and cold chain storage
Inbound Process – Identify Product Quality Complaints and trending of damaged products received. TMD retrieval, downloads, and review
QA Sampling and Quarantine release
General Storage – ensure one product per bin, status labeling where applicable and FEFO application.
Replenishment – FEFO
Release of orders, picking, checking, and packing.
Cycle counts / annual counts – Review of cycle count reports. Report on stock variances that are exceptional and report to Client/PPB if required.
Dispatch of orders – only to registered entities. Compliance of vehicles for transport of pharmaceutical.
Returns process – Quality Assessments on returned goods in accordance with approved criteria, quarterly trending of reasons for returns.
Rejected product management – ensure identification and segregation (logically and physically)
Destruction – in line with local legislation
Recall strategy – ensure recall strategy is in place and complies with PPB and Client requirements.
Report to IMS Senior Management, Clients, and PPB on problems such as Product quality complaints or non-conforming products, stolen goods / hijacks, and counterfeit stock.
Reply on Audit reports from IMS QA/Clients/PPB
Communicate with Clients on various matters that pertain to their business – assist with query investigation.
Initiate / ensure that non-Conformances are initiated, reviewed, and evaluated.
Review Operational performance of staff for continual improvement.
Plan and conduct internal audits in conjunction with QA (MS), according to required Standards (PPB / GWP / ISO 9001:2008) and client requirements.
Participate in external audits.
Compile/review and submit respective reports, with suggested corrective actions, and ensure that corrective actions are implemented within required timelines.
Complete training on SOPs within required timeframe
Determine training needs of business to ensure quality improvement.
Check and monitor compliance of training matrix, training records and the filing thereof.
Review regulatory compliance of various pharmaceutical duties that are carried out by registered staff members.
Ensure staff are trained and aware of GDP requirements.
Review Change Control requests and ensure that Regulatory Compliance is observed.
Ensure Technical/Quality agreements are in place with all Vendors, holders of certificates of registration and 3rd Party Service providers where services rendered directly affects product quality.
Ensure business operations are conducted under direct personal supervision of a pharmacist.
Ensure that staff providing services forming part of the scope of practice of pharmacist is appropriately registered with the PPB.
To ensure that all agreed EMS objectives as per the department are achieved in as far as is practicable.
To ensure that all Corrective Action/ Preventive Actions proposed on internal and external audits are closed out/ implemented within required timeframe.
Qualifications required:
BSc. Pharmacy
Registration with the Pharmacy and Poisons Board in Kenya
Experience required:
Up to 8 years of experience in a similar environment, with at least 5 years operational leadership or specialist experience.
Behavioural competencies:
Knowledge of GWP / GDP
Planning, organization skills
Self-development, Motivation
Decision making, problem solving, creativity.
Analytical preference with attention to detail
Good reading and writing skills in English language.
Good communication skills
Ability to interact at a high level with clients.
Ability to work in a team environment.
Computer literacy
Ability to Up to 8 years of experience in a similar environment, with at least 5 years operational leadership or specialist experience.
Work with minimal supervision.
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