Job purpose

• 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 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;

Requirements

Skills Required

Background/experience

• Bachelors Degree in Chemistry or Microbiology with 5 years’ related experience
• 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