Job Description

Job purpose:

• Coordinate and supervise stability management activities including chamber maintenance, chamber breakdowns and optimal operation of stability chamber according to procedures and guidelines.
• Ensure pharmaceutical compliance with handling, storage, supply, control, recording and destruction of scheduled stability samples.
• Oversee management of the Quality Management System in accordance with Regulatory requirements.
• Performance management of direct reports.

Responsibilities

Planning and Section Management

• Provide input into and independently implement and coordinate systems and procedures.
• Provide section staff with day-to-day direction and tasks.
• Determine, allocate and request required assets and resources for the fulfilment of work objectives; and monitor its use.
• Develop new and facilitate implementation of current processes.
• Propose changes or improvements to management on processes, tools, techniques, and products.
• Provide input into and manage budgets and resource requirements.
• Train and assist junior staff.

Stability Management

• Ensure data integrity and traceability of room conditions.
• Coordinate and conduct inspections of Stability Chambers to ensure readiness and compliance to regulatory guidelines.
• Supervise and coordinate timeous initiation of stability trials, sampling, testing, storage at required conditions, and tracking of samples.
• Supervise and coordinate tracking of results; review, trend and approve stability trial data.
• Review spec alerts and stability data summaries and reports.
• Coordinate corrective and preventative maintenance of chambers.
• Coordinate breakdown repairs within repair time with suppliers/ agents.
• Coordinate execution of maintenance and calibration investigations
• Source spare parts to maintain efficient equipment utilization.
• Optimize equipment usage and performance.
• Implement best operating practices and continuous improvement.
• Write and review quality procedures / ensure adherence to procedures.
• Report on stability trial status, spec alerts and stability investigation status, and stability summary report status.

Reporting and Record-Keeping

• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations.
• Compile detailed reports and consolidated documents.
• Monitor and control access to and set-up of electronic databases.

Governance, Risk & Compliance

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

Background/experience

• BPharm / Diploma in Analytical Chemistry or equivalent with 5 yearsxe2x80x99 related experience
• Supervisory experience
• Stability laboratory and/ or maintenance experience

Specific job skills

• Advanced understanding of stability chamber management and MCC and ICH stability testing guidelines
• Understanding of pharma manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Interrogating Information
• Offering Insights
• Managing Performance
• Planning and Organizing
• Customer Awareness

Aspen Pharmacare