QC Team Leader (East London) at Aspen Pharma Group

Overview

• Manage and coordinate lab preparation and QC activities
• Manage and coordinate sampling and testing of external environment
• 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

Skills Required

Background/experience

• National Diploma in Chemistry or Microbiology with 5 years’ related experience
• Laboratory and Good Laboratory Practice experience
• Minimum of 1 -2  Years Supervisory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• 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 Organising
• Customer Awareness

Requirements
Responsibilities

Planning and Section Management

• Provide input into operational planning of section, and prioritisation 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

QC Lab Testing

• 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
• Proficient in Empower, Lab-X and LabSolutions usage
• Manage AMDV / AMT protocols, execution and review of AMDV / AMT outcomes
• Manage all OOS investigations and conclusions, and report to management

Environmental Management

• Manage and coordinate sampling and testing of external environment, according to SOPS and sampling plan/ schedule
• Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Lab Quality Reviews & Training

• Validate batch documentation approvals
• Review and approve corrections in batch documentation
• Identify and coordinate training of staff on SOPs
• Compilation of biannual trend report
• Proficient in SAP, LIMS, SLIMS, Veeva Docs, Process Compliance

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;