Quality & Compliance Manager Job, Kenyan Accounting Jobs 2023,
Job Function
- Lead the quality and compliance function, and its implementation across the organization.
- Ensure proper internal controls are in place to mitigate against quality & compliance risks by independently assessing the control environment.
- Work in collaboration with the Managing Director and management team to promote a value-based compliance culture through communication and training initiatives.
- As the Risk Champion, support the business to proactively identify and manage risks in all aspects of the business unit’s strategy and operations,
- Advise the management team in the business on risks associated with emerging business strategies and pragmatic options for risk mitigation.
Key performance areas:
Quality Assurance
- Accountable and responsible for the company’s Quality Management System
- Oversee self-inspections of Surgipharm Limited facilities – Nivina Towers, Kings Business Park and Surgipharm Limited Mombasa Branch.
- Ensure third-party qualification and oversight.
- Develop and review Quality documents including SOPs, GDP deviations, validation reports etc.
- Observe and comply with the Company Standard Operating Procedures (SOPs).
- Observe and comply with WHO, Local and relevant regulatory standards set on Good Distribution Practices and Good Storage Practices (GDP & GSP).
- Observe and comply with Health and Safety Requirements of Kenya and compliance with International Standards.
- Act as a backup in the absence of the QA Officer for receipt & release of pharmaceutical products as per advice from Principal Companies
- Create and deliver quality related internal trainings related to GDP.
- Ensure final disposition for returned, recalled, and rejected products and responsibility to accept returns into saleable stock in lieu of warehouse manager.
- Ensure third-party qualification and oversight.
- Coordinate product recalls and handle technical complaints with the help of the warehouse manager, branch manager Mombasa and regulatory affairs manager.
- Report metrics and trends of product complaint program and other quality systems as assigned.
- Participate in compliance processes, procedures, audits and CAPAs.
Compliance
- Ensure annual ABAC certification and conflict of interest declaration is undertaken by staff.
- Drive accountability throughout the organisation toward greater business transparency.
- Ensure and effective Compliance and whistle-blowing culture & programme.
- Partner with Management team to proactively assess and manage risks in a way that enables the organization to deliver sustainable business growth.
- Accountable for ensuring proper internal controls are in place by independently assessing the compliance framework.
- Report all major or critical audit findings/non-compliance (from internal, national authority, customers and principal audits) to the head of the business and Imperial central team as soon as its identified.
- Coordinate and interact with all other staff involved in risk identification and management at the operation and interface with the relevant functional risk owners to obtain risk information and/ or assistance.
- Ensure principal specific requirements (contracts, code of practice, quality agreements) are complied with, in including these in written controls
- Custodian of the business risk register.
- Ensure effective Risk Management Committee meetings are undertaken per agreed frequency and agenda.
Nature of position
- Permanent
Qualifications required:
- Bachelor’s Degree or equivalent.
- Diploma holders with more than 5 years relevant work experience will be considered.
- 4 – 6 years of relevant work experience in the pharmaceutical industry
- Audit/ risk management experience.
- Quality Management Systems/Internal Audit Auditor certification will be an added advantage.
- Pharmaceutical license is preferred.
How to Apply