Job Summary: Responsible for enforcing quality assurance processes/procedures in relation to quality risk management (QRM), SMF (Site Master File), quality management (QM), standard operating procedures (SOPs), change control, deviation, temperature mapping, product quality review (PQR), corrective and preventative action (CAPA)
Also responsible for providing leadership, training to the team to foster a culture of compliance to all set standards of quality, especially WHO GMP standards.
Key Responsibilities:
To prepare Quality Assurance section Standard Operating Procedures (SOPs).
Responsible for effective implementation of the process and documentation of change control and deviation management.
Coordinate quality activities such as temperature mapping study in temperature controlled storage areas.
To draft and update the site master file and quality manual.
Oversee preparation of Product Quality Review (PQR) for all products in a timely manner and see to it that necessary corrective and preventative action (CAPA) is initiated as per the results of the PQR.
Monitor CAPA for its timely completion.
Provide support to the Head of QA during site inspections conducted by external parties.
Take the lead in carrying out quality risk management (QRM)
Coordinate with the Human Resource Department to ensure that the team has up to date and documented job descriptions and organograms at any one time.
In concert with the HR department, ensure that medical examinations are carried out for all production staff in contact with raw materials and Work in Progress (WIP) during the production process.
Enhance awareness to cGMP through participating in self-inspections and training.
To adhere and comply to; all cGMP and GDocP records/data standards, ALCOA principles, and the company code of conduct for data integrity
Continuously seek opportunities and suggest ways to improve the quality management systems.
Any other duties that may be assigned from time to time.
Principal outputs for this role
Compliance to regulatory (quality) requirements as evidenced by quality audit reports
Proactive follow-up and timely completion of CAPAs
SOPs and quality standards in place and regularly updated
Complete and successful quality risk management activities
Up to date JDs for all staff and timely medical examinations done
Competencies
A good understanding of various manufacturing practices, processes and principles.
Strong communication skills with various levels of the organization
Ability adjust work schedule based on business requirements
Attention to detail and an affinity for high standards.
Good people management skills
Qualifications & Experience
Bachelor’s Degree in Chemistry, Pharmacy or related field
Minimum five years’ experience in quality assurance management two of which should be at a supervisory level
Pharmaceutical industry or experience within a highly regulated technical industry environment e.g. GMP
Experience with Pharmaceuticals quality management systems.
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