Job Description/RequirementsJob SummaryReportingto the Quality Assurance Manager, the positionwill be responsible for enforcing QMS planning, maintaining &monitoring compliance to all the procedures in relation to quality riskmanagement while ensuring all QMS documentation are up to date. The position willalso provide leadership, and training to the team to foster a culture of commitmentto all set standards of quality, especially WHO GMP standards.Key Responsibilities• To prepare and review Quality Assurance section Standard Operating Procedures (SOPs).• Responsible for effective implementation of the process and documentation of change control and deviation management.• To prepare and update the site master file and quality manual.• Ensure 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 and evaluate all CAPA for its timely completion and check their effectiveness• Participate throughout its life cycle during site inspections conducted by both internal and external parties.• Take the lead in planning and carrying out quality risk management (QRM)• 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..• 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.• To ensure safe custody, archival of documents and ensure they are upto date• Ensure the management and efficiency of your departmental staff and take necessary actions and decisions in regard to employee life cycle activities e.g. recruitment, trainings, performance management, motivation, discipline management and separation in line with HR policy.• Any other duties that may be assigned from time to time.Qualifications• Minimum Diploma 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.• A good understanding of various manufacturing practices, in pharmacy set-up• 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• Computer Literacy i.e. Ms. Word, Excel, PowerPoint, Access etc.
1 month ago Jobs Offers Nairobi 78 views
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