QC COMPLIANCE LAB ANALYST X2

WADEVILLE
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Reporting to Compliance Supervisor/QC Laboratory Manager

Ensure adherence to compliance documentation / Administrating

Job Purpose of Laboratory Software. Ensure cGLP, GMP, GDP, Audits and SHE
compliance are adhered with regards to all Quality Control
activities

 BSc Chemistry/ Diploma in Analytical Chemistry

Required Learning  Minimum of 5 Years’ experience in pharmaceutical industry
 Computer literacy especially MS Office
 Experience in operating laboratory equipment’s
 Broad knowledge of GMP regulations, Good Laboratory Practises
and WHO

Key Job Outputs  To ensure compliance to specifications prior to release.

 Evaluate data packs for all new or current updated Raw materials,
Bulk, finished products, Post Imports components and
consumables by means of desk study
 Evaluate change control and initiate change control requests for
specification and test procedure updates
 Change controls and non-conformities to be timeously reported
and closed off.
 Ensure standard operating procedures, specifications and methods
are updated timeously and that they are drawn as per current
guidelines.
 Analytical evaluation/validation required for compilation of
specification and test procedure, identify and request new item
numbers
 Accurately interpret, calculate results assist analyst with model
calculation confirmation.
 Provide detail observations from the analysis of data and
interpretation of results.
 Assist in solving all related analytical and instrumental problems
experienced.
 Ensure that all queries are actioned as per QA and QC request
 Ensure that all deviations, investigations are executed and
completed as required as per defined timelines.
 Investigate and initiate corrective actions for all quality deficiencies
 Evaluate / complete all records and reports timeously and
accurately as described in the relevant SOP’s, protocols and
associated documentation before they are sent to the Quality
Assurance Department.
 Draw up new protocols for verification method and method
transfer
 Ensure that products are produced accurately, tested and stored
according to the required SOP’s and documentation.
 Assist in complying training schedule for the year in QC
Department.
 Assist with Audit readiness
 Administrate of Laboratory Software:
Customize management of project information by
Creating Mother Project on empower and its subproject
Creating instrument method, Method set and processing method
and
acquiring sample sets
Defining custom reports and create Assay report / processing
report on the software.
Creating and adding custom fields, and calculating custom
database results during qualification or update of Empower
Software.
Ensure that all data acquisition is complete and all users are
logged out of the Empower application (Shutting Down the Clients
and Chromatographic Systems /reboot once as per SOP)
 Perform Project back-up and review of data backed-up.
 Update of Empower Software SOP and perform training.
 Assist Analyst with Empower related queries.
 Report any Empower software application status and error
messages appear on the massage centre.
 Ensure compliance to quality management system is adhered to
with respect to:
Out of Specification (OOS)
Out of Trend (OOT)
Deviations
Change controls
 CAPA
Incident report

 Customer Service Orientation

 Ensure cGLP, GDP, SAHPRA and SHE compliance are adhered to
Core Competencies
with regards to all Quality Control activities
 Attention to detail.
 Problem-solving Skills.
 Good Verbal and written communication skills.
 Teamwork.
 Planning and organizing.
 Ethical responsibility.
 Good time management.
 Continuous Improvements.

 Compliance to Password/user access to software as per data

integrity declaration

 Good Documentation Practices / integrity of all data generated and

reviewed.
 Ensuring Health and Safety compliance
 Personal Protective Equipment (PPE)
 Safety Data Sheet for chemicals used in the laboratory (SDS)
 Good housekeeping, GLP, GMP and GDP in the laboratory
Interested parties who meet the above requirements may email their cv,
Enquiries/ certified ID copy and qualifications to
Applications [Link]@[Link]
with the name of the position in the subject line. Closing date will be 19
June 2023