Quality Assurance Pharmacist

1 week ago

Midrand, Gauteng, South Africa RNB Placements Full time
Our client, Pharmaceutical Manufacturing concern, has a role for a QA Pharmacist to join their team.

Purpose of position:


Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems as per regulatory, cGMP, Pharmaceutical Industry Guidelines, ISO 9000, FKSA and Global requirements, as applicable.


Key Responsibilities:

1.

Quality Agreements:

  • Initiate and maintain Quality / Service Level Agreements for all GXP Suppliers for all branches
  • Perform 3 yearly review of all SLA's
  • Maintain the status on the Approved Supplier list

2.

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.
  • Monthly 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 during the supplier management process
  • Key involvement in all Corporate audits to ensure support is provided where required
  • Key involvement in all regulatory audits to ensure support is provided where required

3.

KPI reporting & Annual Quality Management Review:

  • Supply of required inputs to KPI reporting for local, region and global on aspects related to Quality Assurance function
  • Prepare slides for Annual Quality Management Review Meeting

4.

Supplier Management:

  • Maintain a system for supplier evaluation and approval prior to purchase i.e Supplier Qualification.
  • Coordinate corrective actions stemming from supplier performance reports
  • Perform for cause audit of noncompliant suppliers that may be outside of annual audit plan.
  • Maintain the Approved Supplier List with current information as and when required
  • Maintain the supplier quality requirements on SAP.

5.

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
  • Ensure relevant global SOP's are adopted locally as required timeously.

6.

Quality Systems:

  • Investigation, closure and follow up on applicable Risk Assessments, CAPA, Change Controls and Events to ensure timely closure and effectiveness of corrective action

7.

Product Release:

  • Review and evaluate BMRs and BRLs prior to final product release.
  • Evaluation of documentation to release products.
  • Processing of product release transactions

8.

General:

  • Provide and support the Senior Quality Systems Manager/Head of Quality with related quality projects as and when required
  • Assist the QA Document Controller with issuing Production Documents.
  • 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
  • Ensure all training planned is completed within timeframe.

Desired Experience & Qualification

Qualification:

  • Minimum BPharm degree

Skills & Experience:

  • 6 years' or more experience in Manufacturing and with QC (essential)
  • Work experience in a sterile environment preferred.
  • Experience with medical devices (essential)
  • Thorough knowledge of cGMP principles
  • Knowledge of ISO 9000
  • Knowledge of quality auditing
  • Knowledge of supplier management
  • Understanding of legislation for Manufacturing Pharmacy and regulatory processes
  • General Management

Salary:
R50 000,00 - R65 000,00 per month

Education:

  • Bachelors (required)

Experience:

Quality Assurance: 6 years (required)

Ability to Commute:

  • Midrand, Gauteng (required)

Ability to Relocate:

  • Midrand, Gauteng: Relocate before starting work (required)

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