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QUALITY ASSURANCE PHARMACIST (AA) - 361900
QUALITY ASSURANCE PHARMACIST (AA)
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
QUALITY ASSURANCE PHARMACIST (AA)
Pharmaceutical Manufacturing Sector
Multi-national Pharmaceutical Manufacturer seeks suitably qualified / experienced QA Pharmacist to join their dynamic team.
The successful candidate will be responsible for implementing and maintaining all elements needed to ensure compliance with Quality Assurance principles and systems as per cGMP, Company’s Local and Global requirements as applicable.
Shortlisted candidates must have min 3 Years exp with manufacturing Parmacy as Quality Assurance
Duties & Responsibilities
KPI’S WILL INCLUDE:
Initiate and maintain Quality / Service Level Agreements for all GXP Suppliers for all branches
Initiate annual audit plan for both internal and external audits, plan, execute, report on and follow up on all observations noted to ensure timely close out.
Quarterly update to internal and external audit plan with valid reasons provided if audits are postponed, also indicating audits that were conducted.
Conduct as needed audits of processes/ departments or suppliers as may be necessary resulting from problems that arise from time to time
Key involvement in all Corporate audits to ensure support is provided were required
Key involvement in all regulatory audits to ensure support is provided were required
Supply of required inputs to KPI reporting for region and global on aspects related to Quality Assurance function
Maintain a system for supplier evaluation and approval prior to purchase
Co-ordinate corrective actions stemming from supplier performance reports
Perform audit of non-compliant suppliers that may be outside of annual audit plan.
Maintaining the approved supplier list
Management of Customer complaints
Monitor the complaints system – Sharepoint and gCMW to ensure effective complaint management
Standard Operating Procedures
Ensure all SOP's required within the department are initiated, updated, trained and current.
Review of applicable SOP’s ensuring that new requirements are incorporated and taking Global requirements into consideration
Investigation, closure and follow up on applicable Risk Assessments, CAPA, Change controls and deviations to ensure timely closure and effectiveness of corrective action
Assist the Quality Control Manager with product releases over weekends on a roster basis or as and when necessary.
Submission of Adverse Drug Reactions on Company global database - to be trained as a back-up for PV Pharmacist
Receipt of ICSRs
Follow-up of ICSRs
Report ICSRs via COSI for evaluation
Log ADRs with batch/lot number on Sharepoint
Provide and support the Senior Quality Systems Manager/Head of Quality with related quality projects as and when required
Effective provision of QA support to the branches, assist in and conduct QA related investigations as needed
Establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the company
Bachelor of Pharmacy Degree
Registered with the SAPC (South African Pharmacy Council)
Minimum of 3 years’ experience in a pharmaceutical manufacturing environment
Work experience in a sterile environment preferred
Thorough knowledge of cGMP principles
Knowledge of ISO 9000
Knowledge of quality auditing
Understanding of legislation for Manufacturing Pharmacy and regulatory processes
People Management / General Management experience