Aspen Pharma Group ikhangela i QA Pharmacist, eMonti, eMpuma Koloni.
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Aspen Pharma Group ikhangela i QA Pharmacist, eMonti, eMpuma Koloni.
OVERVIEW
Conduct in process compliance to quality procedures, standards and specifications for value stream operations. Review and approve quality related activities for value streams. Identify and provide solutions to systematic issues. Review Annual Performance Quality Review (APQR) and perform related administrative tasks.
RESPONSIBILITIES
PLANNING and PROCESS
Provide technical and operational input during drafting of plans and procedures specific to unit.
PROCESS COMPLIANCE
Execute day to day QA activities for value streamsIdentify systematic technical and process issues by reviewing CAPA requests and trends
Systematic investigation of the root causes of identified problems and risks for corrective action or prevention
Develop CAPA plans and change incidents to address process complianceImplement operational changes to SOPs and processes, in compliance with control processes
Ensure deviations (planned/ unplanned) and concessions are documented, reviewed, and analysed; and recommend validation activities to be performed
Execute change control process by ensuring changes are documented, reviewed and approved
ANNUAL PERFORMANCE QUALITY REVIEW
Review APQRs to assess production risks and quality of in process control programsReview and analyse CAPA plans to assess impact on quality procedures and standards
RETENTION SAMPLE MANAGEMENT
Store and manage retention samples as per guidelines
IN-PROCESS QUALITY MANAGEMENT
Review and approve outcome of in process internal inspections
REPORTING
Monitor the storage of documents on the soft and hard copy filing systems
Maintain and update records and systems as required
Provide information for reports on weekly/monthly basis, as required by superior
Compile standardised reports and consolidate documents
SKILLS REQUIRED
BACKGROUND/EXPERIENCE
Bachelor’s degree (B Pharm) with 4 – 6 years’ related work experience, or Post Graduate Degree/ Post Graduate Diploma with 2 – 4 years’ related work experience
Pharmaceutical manufacturing experience
SPECIFIC JOB SKILLS
Advanced understanding of the pharmaceutical manufacturing and corrective action programsPharmaceutical standards and compliance requirementsAbility to interpret and implement policies, processes and objectives
COMPETENCIES
Information Gathering
Interrogating Information
Offering Insights
Taking Action
ADDITIONAL INFORMATION
While you apply for this position, please note that MZANSI EKHAYA is not accountable for any errors and enquiries. For further assistance, please contact the employers using the information provided on this article or search the company website/contacts.
Closing Date yi 29 ka November 2023
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