Job purpose

• Lead the Centralized Quality Control projects and services, including Stability Management, Investigations, Packaging Testing, Quality Systems and maintenance of laboratory instruments and equipment.
• Manage and guide the unit through team leaders.
• Performance management of direct reports and unit

Responsibilities

Planning and Unit Management

• Interpret, implement and provide technical and operational input into processes, procedures and policies, and monitor operational objectives and plans.
• Make decisions regarding exceptions to policy and procedures.
• Plan, track and collaborate all QC central activities to ensure objectives are met.
• Identify gaps in current policies and procedures.
• Build and maintain relationships with internal/ external stakeholders.
• Provide input into the financial plan and manage budget.
• Ensure availability and optimal allocation of resources within unit.
• Perform HR functions to ensure optimal management of unit.
• Propose changes/improvements to processes, tools and techniques for continual improvement and regulatory compliance.
• Identify training needs of QC Central staff.

Stability Program Management

• Report on storage capacity, calibration, validation and maintenance of stability chambers
• Lead a comprehensive stability study program.
• Oversee data management of local and international stability trials for all Aspen products, and 3rd party products where required.
• Manage the review and approval of stability results and OOSs.
• Manage the Stability Forum and present stability OOS alerts, outcome of technical and analytical investigations, and proposed solutions to product stability failures.

Specification Management

• Manage new specification and methods activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications.
• Manages routine specification updates based on evaluation and interpretation of current vs latest Pharmacopeial routine requirements.
• Provide expertise and manage communication in order to resolve specification queries from internal and external customers.
• Request special investigations, assess outcome of these and initiate the appropriate actions to minimise risk/ instil preventative measurements.

 Technical Transfer management – Analytical

• Manage the development and implementation of method validation, verification and transfer activities in support of technical transfers according to set timelines.
• Ensures the completion of process validation testing in support of technical transfers
• Ensures that methods are in line with regulatory requirements.
• Provides technical support to the QC Laboratories

 Laboratory investigation management

• Manage scientific investigations across site laboratories.
• Develop systems and processes for conducting laboratory investigations within GMP environment.
• Provide assistance to the QC laboratories with problematic laboratory investigations.

Equipment Calibration and maintenance

• Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
• Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
• Ensures new equipment is qualified and commissioned within set timelines.
• Assist and supports the QC laboratories with equipment trouble shooting.

 Packaging Testing

• Oversee the QC testing and release of packaging materials for adherence to standards.

Quality Management Systems

• Equipment Calibration and maintenance
• Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
• Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
• Ensures new equipment is qualified and commissioned within set timelines.
• Assist and supports the QC laboratories with equipment trouble shooting.

Governance, Risk & Compliance

• Equipment Calibration and maintenance
• Manage all laboratory equipment maintenance, calibration, and compliance activities and adherence to specified timelines.
• Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures.
• Ensures new equipment is qualified and commissioned within set timelines.
• Assist and supports the QC laboratories with equipment trouble shooting.

Requirements

Skills Required

Background/experience

• Minimum of Bachelors Degree in Chemistry or Pharmacy with 10 years’ related work experience
• Supervisory experience
• Analytical laboratory and specifications management experience

Specific job skills

• Expert knowledge and advanced understanding of packaging testing, and raw material and finished product analysis.
• Advanced understanding of pharmaceutical and pharmacopeial testing, ICH stability guidelines and regulatory body guidelines for specifications and methods of analyses
• Advanced understanding of pharmaceutical manufacturing and corrective action programs, standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Offering Insights
• Creating Opportunities for Collaboration
• Customer Awareness