QC Team Leader (Port Elizabeth) at Aspen Pharma Group

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.

QC Lab Testing

• Manage and monitor compliance of QC lab testing activities to GMP, quality standards and product specifications.
• Manage and co-ordinate 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.

Environmental Management

• Manage and co-ordinate sampling and testing of external environmental, according to SOPs and sampling plan/schedule.

 Lab Quality Reviews & Training

• Validate batch documentation approvals.
• Review and approve corrections in batch documentation.
• Identify and coordinate training of staff of 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 and Compliance

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

Requirements

Background/experience

• Bachelor’s degree in chemistry / microbiology with 5 years of related experience.
• Laboratory and Good Laboratory Practice experience.
• 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.