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Mar 11, 2021

QC Manager Sterile

  • ASPEN Holdings
  • East London, South Africa
Full time QA-Quality Control

Job Description

Reference Number SVPCIBI


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.

 

Duties & Tasks (Description of the main duties & responsibilities associated with the role):

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

Requirements
Background/experience

7 years’ related work experience
Pharmaceutical manufacturing experience
Minimum of Bachelor’s degree preferred
Work Level
Management
Job Type
Permanent
Salary
Market Related
EE Position
Yes

Salary

Market Related

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