Job Description

• 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 SOPxe2x80x99s and documentation.
• Performance management of direct reports

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

Environmental Management

• Manage and coordinate sampling and testing of external environment, 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 t raining 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.

Skills Required

Background/experience

• Bachelorxe2x80x99s degree in chemistry or microbiology with 5 yearsxe2x80x99 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