Quality & Compliance Manager
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
