Job Description

OverviewManage and co-ordinate lab preparation and QC activities. Manage and co-ordinate 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 SOPs and documentation. Performance management and of direct reports.ResponsibilitiesPlanning 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 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).

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.

Skills RequiredBackground/experience

• Bachelors 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.

Competencies

• Interrogate information.
• Managing Performance
• Planning and Organising
• Customer Awareness

Aspen Pharmacare