Locum QA Pharmacist

 

Recruiter:

Full Circle Recruitment Services

Job Ref:

CN-LQA

Date posted:

Wednesday, March 31, 2021

Location:

Johannesburg, South Africa

Salary:

TBD


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



 

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