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Friday, February 10, 2017

Head of Quality Assurance Job in Nairobi, Kenya

Job Title: Head of Quality Assurance
Job Code: HQA/CP/170209
Number of Positions Open: 1
Reports To: CEO
Location: Nairobi, Kenya
Closing Date: Open Until Filled
Summary: Our Client is mid-sized leading and growing company in East Africa and based in Nairobi, Kenya and is aspiring to get products WHO Prequalified as a first step and thereafter achieve higher standards e.g. MHRA, US FDA etc.
Job Summary: This is an opportunity for a talented, highly skilled and experienced quality systems professional with leadership experience and a background in the pharmaceutical industry to take their next step.
The individual will be responsible for leading the operational excellence initiatives in the QA department and company. He or she will report directly to the CEO. This is a senior leadership position, leading a team of 40 people.
Through a quality systems approach he/she will ensure all internal and vendor GMP operations are in compliance.
The company is mid-sized leading and growing company in East Africa and based in Nairobi, Kenya and is aspiring to get products WHO Prequalified as a first step and thereafter achieve higher standards e.g. MHRA, US FDA etc.
This is your chance to make a difference by contributing in a goal to make available quality and affordable medicines to the needy.
Primary Responsibilities:
  • Ensure the Quality Management Systems are compliant with cGMPs and are operating in a state of control.
  • Overseeing the handling of Change Controls, Deviations and CAPA’s through effective quality management tools.
  • Prepares and manages internal and external audit, reports, evaluates and tracks follow-up actions, and measures effectiveness of associated CAPA.
  • Incorporates risk management principles into the management and decision making process while promoting quality awareness and continuous improvement.
  • Acts as liaison for auditors and government agents.
  • Investigate and evaluate product non-conformances.
  • Develop and evaluate test plans to improve production processes.
  • All complaints, investigations and deviations are properly documented and closed in a timely manner.
  • Stability protocols and programmes.
  • Oversee and ensure data/record integrity.
  • Ensures the Quality Control Laboratory is compliant with GLP and overseeing the QC department.
  • Ensure all materials received are properly reviewed by Quality Control in order to ensure that any issues or discrepancies are discovered prior to a production run.
  • Writing compliant SOPs for the Company and maintaining the SOP systems.
  • Overseeing the approval and release process of all documentations.
  • Conferring with Production and Engineering to ensure all Preventive Maintenance, Calibrations and other facility related measures are being conducted and documented as per requirements.
  • Overseeing the release of Batch Records and Reconciliations.
  • Manage all cleaning, process validations, IQ, OQ, and PQ.
  • Ensure all log books as specified are maintained and properly documented.
  • Leadership – mentor, coach, direct, lead and motivate a team of professional, technical and administrative staff in focused, collaborative and constructively coordinated execution of quality operations duties.
  • Recruiting, training and development of Quality personnel is done effectively and in a timely manner and documented.
  • Assisting in all new product launches by providing quality standards.
  • Oversee Annual Product Reviews.
  • Keeps informed about current GMP and suggests areas of improvement.
  • Creates and embraces a Quality culture.
Performance Standards: Organisation passes all audits. In particular, as a first step WHO Pre-qualification standards. There will be an additional bonus attached to this achievement.
Skills and Certification:
  • 10+ years’ QA experience in the Regulated Pharmaceutical industry.
  • 3+ years’ experience in direct management.
  • Extensive experience and knowledge with GCP, GLP, and ICH, WHO, US FDA Guidelines.
  • Assertive, confident, team player and strong leadership attributes.
  • Strong problem solving skills, investigational, CAPA and CAPA implementation.
  • Strong auditing skills.
  • Excellent technical skills.
  • Planning and organisation skills.
  • Computer software knowledge – Word, Excel etc.
  • Excellent maths, English (spoken and written) and writing skills.
  • Strong attention to detail.
  • Graduate (Bachelors, Masters) in Science or any similar field.
How to Apply:
Interested candidates holding the necessary requirements, good performance and / or references are encouraged to apply with detailed CV’s, inclusive of names and contacts of 3 referees, current telephone number and email address by clicking on: Head of Quality Assurance

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