Job Description
Reference: REGSEP16
Key Performance Area and Essential Duties
Standard Operating Procedures
Initiate, implement and review SOP’s to reflect current regulatory requirements and GDP practices.
Update and maintain the SMF as applicable.
Review and approve all SOP’s for regulatory compliance.
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 with in country regulations.
Products Quality Compliance – Operations
Responsible for regulatory conformance to the Operations in Kenya with regards to:
Compliance to all approved SOP’s
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 FEEFO application
Replenishment – FEEFO
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.
Review and approval of all inventory adjustments.
Dispatch of orders – only to registered entities.
Compliance of vehicles to transport 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)
Recall strategy – ensure recall strategy is in place and complies with PPB and Client requirements.
Destruction – in line with local legislation
Reporting
Report to Imperial 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 IHS QA/Clients/PPB
Communicate with Clients on various matters that pertain to their business – assist with query investigation
Non Conformances
Initiate / ensure that Non- Conformances are initiated, reviewed and evaluated
Management and Control
Review Operational performance of staff for continual improvement.
Establish systems for effective control of regulatory compliance in line with PPB requirements.
Implement systems for effective control of regulatory compliance.
Managing staff according to Key Performance Areas.
Monitor and ensure Pharmaceutical compliance to establish depth and management of team through appointment, induction training and development of staff.
Induct new Clients into the QMS via project management, with respect to Regulatory/Product compliance.
Audits and CAPA’s
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.
Staff and Training
Complete training on SOP’s within required timeframe
Refresher training on SOP’s on a monthly basis
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.
Critical System Implementation and Changes
Review Change Control requests and ensure that Regulatory Compliance is observed
Agreements
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.
Responsibility in terms of relevant Act
Ensure business operations are conducted under direct personal supervision of a Pharmacist.
Appoint a Responsible Pharmacist and Deputy to the Responsible Pharmacist for each site.
Have appropriate qualifications and experience in the services being rendered.
Ensure that staff providing services forming part of the scope of practice of pharmacist is appropriately registered with the PPB.
Ensure that unauthorized persons do not obtain access to pharmaceutical products or premises outside of normal trading hours.
Ensure the safe and effective storage and keeping of pharmaceutical products.
Ensure that all applicable registrations and licenses are maintained, current and in place.
Product Registration and Regulatory affairs
Ensure that client products are registered and retained as per the PPB regulations and other Regulatory bodies within the region.
To follow-up registration with Drug Authority (includes follow up visits to Drug Authority during the registration period) if Principal submits/compiles dossiers to Drug Authority.
Preparations and submission of Pharma and Non Pharma Advertisements, for Regulatory body approvals
Application and follow-up of registration of trademark with trademarking authority-KIPI.
Pharmaco-vigilance activities such as Adverse Event reporting.
Import and export permit processing for Registration samples.
Business Directorship role
Ensure that the company complies with the Company’s Act.
Participating Board of Directors meetings and AGMs.
Qualifications required
Minimum tertiary qualification (B.Pharm)
Masters in Pharmacy
Registration with the Pharmacy and Poisons Board
Skills and experience required
Previous experience in an executive Pharmacist role preferably in Warehousing setting
Working knowledge of the Pharmacy and Poisons Board Acts
Knowledge of Good Wholesale/Distribution Practice
Previous experience in product registration and trade affairs
Good planning and organization skills
Executive level decision–making, and problem-solving capability
Good Leadership skills
Self-starter who is able to develop relationship and engender transparency
Be accountable to internal and external stakeholders
Ability to interact at a high level with clients, senior management and authorities
Analytical skills, attention to detail
Other requirements
Ability to interact with high level clients
Previous experience dealing with KEBS
Must be numerate and analytical
Ability to work under pressure
Positive, confident, self-motivated and able to work as a member of a team
