JOB PURPOSE:
To work with relevant quality staff to develop comprehensive quality programs that will ensure the maintenance of laboratory QMS to internationally recognised GCLP standards. Expansion of the QMS to other areas of the laboratory in order to qualify for GCLP accreditation.
Description:
REPORTS TO: Head of Biosciences
DIRECTLY SUPERVISES: Laboratory Quality Assurance Officer
JOB DIMENSIONS:
To work with relevant quality staff to develop comprehensive quality programs that will ensure the maintenance of laboratory QMS to internationally recognised GCLP standards. Expansion of the QMS to other areas of the laboratory in order to qualify for GCLP accreditation.
KEY RESPONSIBILITIES:
Manage the laboratory quality team and develop a quality management structure for the laboratory.
Develop, monitor and implement quality assurance compliance objectives and programs and report on progress/ level of compliance.
Participate in the development, review, update and implementation of quality policies, procedures and monitoring tools.
Liaise with managers and operating staff within the laboratories to ensure that QA/QC procedures are continuously monitored with well documented corrective action where appropriate.
Monitor, collate and analyse adherence, uptake of staff and performance data and charts against defined parameters to identify areas for growth and generate reports.
Acting as a catalyst for change, being creative in formulating strategies to encourage staff to implement QA/QC processes and improve performance and quality.
Training, motivating, coaching, and correcting employees to ensure that standards are met.
Organise internal audits as per identified auditable areas, train internal auditors, co-ordinate internal audits and ensure document all audit findings are documented.
Liaise with the external auditors, monitors and inspectors in conducting audit activities including scheduling audits, facilitating audits and working with relevant staff to implement actionable areas/findings.
Maintain laboratory staff training database, identify and coordinate quality related training needs, develop training programs and materials and conduct training.
Promote quality achievements and performance improvement within and throughout the laboratories.
Coordinate regular QMS performance meetings with designated personnel from each laboratory discipline to communicate objectives, discuss performance and identify areas of improvement.
Ensure maintenance and control of laboratory QMS records and documentation.
Prepare and submit reports as and when required.
Deputise and fill-in for other quality staff as may be required.
And any other duties that may be assigned from time to time.
QUALIFICATION:
Masters degree in Biomedical Sciences or equivalent.
At least 8 years’ experience working in a medical/ research laboratory with at least 5 years’ experience as a Quality Assurance Officer.
Professional qualification in laboratory quality assurance/ control
Training in quality management systems, quality assurance programs or equivalent
Sound knowledge and understanding of lab QMS’s, GCLPs and other relevant best practices and standards.
COMPETENCIES:
Strong analytical and follow through ability; attentive to detail.
Ability to follow laid down processes and procedures.
Confidentiality and integrity
Planning and organizational skills
Excellent interpersonal and communication skills
Team working and ability to work in a multi-cultural environment.
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