Site Quality & Compliance Lead and Responsible Pharmacist (East London)
Core
Lead, manage, and implement site quality systems and plant quality in compliance with South African/Sub-Saharan Africa regulations and Kenvue standards while acting as the Responsible Pharmacist.
Role type
Senior Quality & Compliance Lead / Responsible Pharmacist
Builds
OTC pharmaceutical products (NEUTROGENA, AVEENO, TYLENOL, etc.)
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
GMP compliance, Quality System management, CAPA management, Internal/External audit coordination, Supplier management, Product recall management, Regulatory agency liaison, Quality budget management, Change control, Product release approval
Preferred skills
SAPC registration, Responsible Pharmacist eligibility, Veeva/BPCS/Tru/Symphony proficiency
Technologies
Veeva, BPCS, Tru, Symphony, Microsoft
Responsibilities
Lead and oversee compliance of site quality system and plant quality processes; Review and implement quality system elements and regulatory requirements; Coordinate and monitor quality system KPIs (NC, CAPA, Global Change Control, Internal Audits); Manage direct and indirect material suppliers; Conduct site quality management reviews and oversee product quality review reports; Oversight of quality control laboratory activities and on-time release of materials and finished products; Administer quality electronic systems; Conduct leadership quality Gemba walks on the shop floor; Handle and escalate critical quality holds; Conduct product recalls, market withdrawals, and regulatory notifications; Connect with external regulatory agencies for site certification; Ensure QA and Manufacturing functions comply with SAHPRA and local Acts; Oversight of quality budget expenditure (CAPEX and OPEX).
