Qc Analytical Team Leader - East London, South Africa - Aspen Pharma Group

Aspen Pharma Group
Aspen Pharma Group
Verified Company
East London, South Africa

2 weeks ago

Thabo Mthembu

Posted by:

Thabo Mthembu

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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

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 daytoday 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 riskbased compliance systems
  • Monitor implementation and correct own and/or team compliance with legislation, policies and procedures.

Skills Required:

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Background/experience:


  • Bachelor's Degree in chemistry or Microbiology
  • 5 years' related experience in laboratory and good laboratory practice experience
  • Supervisory experience
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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
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Competencies:


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