QC Analytical Team Leader
Aspen Pharma Group
2022/11/30   East London

Job Ref #: ELATL02
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1

Applications are invited to apply for this excellent opportunity that exists for the above-mentioned position. The successful incumbent will report to the QC Site Manager. All applications to be received on or before 07December 2022. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job Description

Overview

  • Manage and coordinate validation testing to support tech transfers
  • Manage and coordinate laboratory specifications & testing methods
  • Provide analytical, maintenance and QC lab support
  • Ensure continuous compliance of lab with GMP standards
  • Ensure that products are produced, tested, and stored according to the required SOP’s and documentation
  • Performance management of direct reports
Job Requirements

Responsibilities

 

Planning and Section Management

  • Provide input into operational planning of section, and prioritization of objectives
  • Provide input into, interpret, and execute policies and procedures
  • Provide input into and manage budgets and resource requirements for section
  • Provide section staff with day-to-day direction and tasks

 

Validation testing to support technology transfers

  • Manage and monitor compliance of QC lab testing activities to GMP, quality standards, and product specifications
  • Manage and coordinate lab preparation activities according to SOPs (samples, working area(s), PPE and lab equipment)
  • Prepare and implement maintenance and calibration schedules and records
  • Ensure set priorities and targets are achieved, identifying constraints and solutions
  • Investigate and report Out of Specifications (OOS)
  • Enforce Good Lab Practice

 

Specification upgrade and maintenance

  • Manage and coordinate specification preparation, upgrade and maintenance projects according to SOPS and project plans

 

Lab Quality Reviews & Training

  • Validate batch documentation approvals
  • Review and approve corrections in batch documentation
  • Identify and coordinate training of staff on SOPs

 

Deviations Investigations

  • Manage and coordinate deviation investigations and reporting
  • Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies
  • Manage implementation of operational changes to SOPs and processes

 

Governance, Risk & Compliance

  • Provide input to QC for improvement of risk-based compliance systems
  • Monitor implementation and correct own and/or team compliance with legislation, policies and procedures.

 

Skills Required

  • Background/experience
  • Bachelor’s Degree in chemistry or Microbiology
  • 5 years’ related experience in laboratory and good laboratory practice experience
  • Supervisory experience

 

  • Specific job skills
  • Advanced understanding of pharmaceutical testing methods and analytical method verification / transfer testing
  • Knowledge of value chain and MCC principles
  • Understanding of pharmaceutical manufacturing and corrective action programs
  • Pharmaceutical standards and compliance requirements
  • Ability to interpret and implement policies, processes and objectives

 

  • Competencies
  • Interrogate Information
  • Managing Performance
  • Planning and Organizing
  • Customer Awareness