Summary
The Incumbent shall be responsible for inspecting procedures and outputs in order to reduce issues on non-conformity as well as identifying mistakes that may affect product quality.

Duties and Responsibilities
Maintains the product list
Assist Regulatory projects that involve QA oversight including stability
changes, updates to labeling etc.
Manage and evaluate (trending) product complaints, deviations, and Corrective
Actions and Preventative Actions (CAPAs)
Development, review, revision,
and implementation of SOPs as required.
Annual product reviews and review of stability reports for compliance with
local regulatory registration
Manage the maintenance of quality agreements with manufacturers, wholesalers, and distributors
Conduct inspections of distributors and wholesalers as necessary as per

GMP requirements
Act as primary quality contact person with Third Party Logistics (3PL) and
as a qualified person for internal quality compliance matters
Implement recall procedures if necessary and perform mock recalls yearly to
ensure our recall procedures are adequate.
Monitor QA aspects of warehousing and shipping practices for compliance
with warehouse procedure manuals
Liaise with customers and regulatory authorities regarding quality matters,
including hosting inspections and responding to observations
Ensure compliance with appropriate SOPs, policies, and guidelines.
Complete mandatory training in assigned timelines upon hire as well as
when new policies, SOPs, and guidance are issued.
Participate in personal development and training sessions as required for
the position.
Work in a safe manner that does not endanger yourself or co-workers. Report any health or safety concerns (internal and external) in compliance with organizational policy and standard procedures.
Must be very conversant in Good Pharmacovigilance Practices and adhere to them.
Strive to consistently uphold organizational core values.

Qualifications and Experience
First degree in Pharmacy or Equivalent
A postgraduate qualification is an added advantage.
At least 5 years experience in quality assurance/ regulatory affairs under cGMP and 2 years in a supervisory or management role,