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Job title: QA Manager: Steriles
Employment type: Full Time
Experience: 7 to 10 years
Salary: Negotiable
Job published: 18 March 2021
Job reference no: 1937032202

Job Description

REQUIREMENTS

  • 7 years' related laboratory work experience which includes a minimum 1 year supervisory experience within a pharmaceutical manufacturing environment
  • Bachelor's Degree preferred
  • Advanced understanding of pharmaceutical testing methods
  • Understanding of pharmaceutical manufacturing and corrective action programs
  • South African citizen

 

RESPONSIBILITIES

 

Overview

Ensure evaluation and control of products and materials are tested in accordance with quality procedures, standards and specifications to meet planned requirements. Monitor and manage the QC lab activities. Guide the unit through team leaders, management of direct reports and unit performance.

Planning and Unit Management

  • Interpret, implement, and coordinate systems, processes, policies and procedures in the unit
  • Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations
  • Provide input into the functional financial plan/ budget based on operational requirements
  • Ensure availability and optimal allocation of resources within unit
  • Perform human resources functions to ensure optimal management of unit and reporting sections
  • Manage collaboration and coordination between reporting units

QC Lab Testing

  • Review and approve maintenance and calibration schedules
  • Ensure all equipment is maintained and calibrated according to SOPs and schedules
  • Approve compliance of QC lab preparation and testing activities to GMP, quality standards, and product specifications
  • Ensure all testing is carried out as agreed/ scheduled
  • Ensure lab outputs meet the agreed standard
  • Ensure staff are trained on SOPs

Deviations Investigations

  • Review and approve operational changes to SOPs and processes Customer Service
  • Ensure queries are resolved in time and within policy
  • Update internal and external customers on progress of queries timeously to meet the agreed schedule

Governance, Risk & Compliance

  • Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
  • Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QC activities

Skills:

Industries: