Locum QA Pharmacist

SUMMARY:
Quality Assurance Pharmacist - Locum

POSITION INFO:

MAIN PURPOSE OF JOB
• Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems as per cGMP, ICH Q10 and Global requirements as applicable
• Ensure in Process Quality Control is effective.
Level of Education:
• B.Pharm
Skills & Experience:
• 2-3 years’ experience in Manufacturing Pharmacy
• Work experience in a sterile environment preferred.
• Thorough knowledge of cGMP principles
• Knowledge of ISO 9000
• Quality auditing experience
• Understanding of legislation for Manufacturing Pharmacy and regulatory processes
• General Management
KEY RESPONSIBILITIES
Quality Agreements
• Initiate and maintain Quality / Service Level Agreements for all GXP Suppliers for all branches
Audits
• 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
KPI reporting
• Supply of required inputs to KPI reporting for region and global on aspects related to Quality Assurance function
Supplier Management
• Maintain a system for supplier evaluation and approval prior to purchase
• Co-ordinate corrective actions stemming from supplier performance reports
Quality In-Process Checks
• Manage Quality checks that are routinely performed within the Compounding Centre.
Staff management
• Draft or update job profiles of relevant jobs as the needs of the department and the organization changes
• Draft performance contracts with staff by setting clear key performance indicators (KPI’s) annually or as required
• Draft and communicate training needs of staff by analyzing previous employee performance and identifying performance gaps on an ongoing basis. Train staff as required.
• Manage and provide ongoing performance feedback to staff as required
• Implement the performance evaluation process by scheduling performance reviews with staff, leading the performance discussion and completing the performance reviews annually
• Manage the department’s recruitment needs by liaising with HR to ensure that recruitment is reflective of Employment Equity targets as required
• Manage the department’s leave by making sure all staff leave has been applied for on ESS and approved as discussed and as required.
• Manage the compliance of policies and procedures within the department by ensuring policies and procedures are effectively communicated to the team as required.
• Ensure appropriate disciplinary action is taken as required
Standard Operating Procedures
• Ensure all SOP’s required within the department are initiated, updated, trained and current.
General
• 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

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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