We are continuously upgrading to new technologies and implementing robust processes to ensure we deliver best-in-quality products to our communities

Quality Assurance Manager

Job Type

Full Time

Qualification

BA/BSc/HND

Experience

5 years

Location

Nairobi

Job Field

Pharmaceutical

Brief Job Description:

Leading, maintaining and continuously improving the Quality Management System (QMS) in line with international cGMP, GDP and GSP standards

Acting as a registered Company Pharmacist, fulfilling all legal and regulatory responsibilities of the role, including the release of finished pharmaceutical products to the market

Ensuring that all processes, specifications, instructions and results comply with the registered dossiers and with national and international GMP, GSP and GDP regulations

Authorizing written procedures and their amendments, including SOPs, cleaning and operating procedures, specifications, analytical methods, validation/qualification and stability protocols, and batch and packaging instructions and records

Managing, reviewing and approving the calibration and qualification of equipment, instruments, facilities and utilities, and the validation of manufacturing processes and cleaning procedures

Reviewing batch records, packaging records and analytical testing records, and approving or rejecting starting materials, packaging materials, intermediates, bulk and finished products

Qualifying, approving and monitoring manufacturers of raw materials, intermediates, packaging materials and finished products, and participating in external audits of vendors and service providers

Conducting regular self-inspections and internal audits, managing inspections by authorities and customers, and ensuring timely closure of resulting CAPAs

Managing, investigating and closing market complaints and managing product recalls, ensuring timely response to customers and regulatory authorities

Ensuring timely preparation, review and approval of Product Quality Review (PQR) reports

Preparing, executing, controlling and monitoring the Quality Assurance CAPEX and OPEX budget

Acting as the back-up QPPV in the absence of the QPPV

Leading and developing the Quality Assurance team

Providing functional and disciplinary leadership

Ensuring regular and effective cGMP and GDP training of all staff

Promoting a strong quality culture across pharmaceutical operations

Qualifications and Experience:

Must Have: Minimum Requirements

To be considered, these minimum requirements must be evident on your resume.

Education: Bachelor of Pharmacy degree

Registered as a Pharmacist in the Republic of Kenya

A minimum of 5 years’ experience in the Pharmaceutical Industry, of which at least 3 years should be in a similar position

Expert understanding of local and international regulations and standards for cGMP, GDP and GSP

Excellent leadership, reporting and organizational skills, with the ability to design procedures and influence as a team player

Self-driven and structured, able to work under minimal supervision, resolve problems in a timely manner and handle high work pressure

Proficient computer skills: MS Word, MS Excel and MS PowerPoint; proficiency in English

• Leading, maintaining and continuously improving the Quality Management System (QMS) in line with international cGMP, GDP and GSP standards
• Acting as a registered Company Pharmacist, fulfilling all legal and regulatory responsibilities of the role, including the release of finished pharmaceutical products to the market
• Ensuring that all processes, specifications, instructions and results comply with the registered dossiers and with national and international GMP, GSP and GDP regulations
• Authorizing written procedures and their amendments, including SOPs, cleaning and operating procedures, specifications, analytical methods, validation/qualification and stability protocols, and batch and packaging instructions and records
• Managing, reviewing and approving the calibration and qualification of equipment, instruments, facilities and utilities, and the validation of manufacturing processes and cleaning procedures
• Reviewing batch records, packaging records and analytical testing records, and approving or rejecting starting materials, packaging materials, intermediates, bulk and finished products
• Qualifying, approving and monitoring manufacturers of raw materials, intermediates, packaging materials and finished products, and participating in external audits of vendors and service providers
• Conducting regular self-inspections and internal audits, managing inspections by authorities and customers, and ensuring timely closure of resulting CAPAs
• Managing, investigating and closing market complaints and managing product recalls, ensuring timely response to customers and regulatory authorities
• Ensuring timely preparation, review and approval of Product Quality Review (PQR) reports
• Preparing, executing, controlling and monitoring the Quality Assurance CAPEX and OPEX budget
• Acting as the back-up QPPV in the absence of the QPPV
• Leading and developing the Quality Assurance team
• Providing functional and disciplinary leadership
• Ensuring regular and effective cGMP and GDP training of all staff
• Promoting a strong quality culture across pharmaceutical operations

• Excellent leadership, reporting and organizational skills
• Ability to design procedures
• Team player
• Self-driven and structured
• Able to work under minimal supervision
• Problem-solving skills
• Ability to handle high work pressure
• Proficient computer skills: MS Word, MS Excel and MS PowerPoint
• Proficiency in English

• Bachelor of Pharmacy degree
• Registered as a Pharmacist in the Republic of Kenya
• Expert understanding of local and international regulations and standards for cGMP, GDP and GSP