Overview

• Ensure evaluation or testing and control of starting materials, consumables, components, intermediaries, bulk and finished products in accordance with Quality procedures, standards, specifications to meet planned requirements
• Develop, manage, monitor and approve Standard Operating Procedures, Methods of Analysis, specifications, protocols and reports in compliance with latest regulations
• Ensure appropriate method validations are performed and up to date
• Long term strategic planning for unit
• Manage, guide and monitor QC Laboratory activities through Team Leaders
• Staff management of direct reports and entire department (KPIs, performance reviews, disciplinary actions and other IR responsibilities)
• Risk identification and solution
• Approve all training to be implemented in the laboratory and ensure unit staff’s training are appropriately trained (initial training as well as re-training and qualification)

Skills Required

Background/experience

• Minimum of Bachelors Degree preferred
• 10 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Innovative Thinking
• Interrogating Information
• Offering Insights
• Managing Performance
• Networking

Requirements

Responsibilities

Strategic Planning and Unit Management

• Interpret, implement and coordinate systems, processes, policies and procedures in the unit
• Provide technical and operational input into systems, procedures and policies that impact in-process control activities in value stream operations
• Perform human capital functions to ensure optimal management of unit and reporting sections
• Manage collaboration and coordination between reporting units
• Responsible to lead projects directly related to the value stream laboratories (Chemistry and Microbiology)
• Liaise, interact and provide technical guidance to QA and Production Managers
• Propose changes / improvements to processes, systems, tools and techniques
• Lead L2 and attend L3 meetings

Financial Planning, Financial Management and Resource Management

• Develop and monitor the functional plan / budget (OPEX and CAPEX) of the value stream laboratories (Chemistry and Microbiology)
• Ensue availability and optimal allocation of resources within unit

People Management and Development

• Implement Human Capital Policies
• Identify training needs and monitor training compliance
• Participate in training, coaching and development of team members
• Develop and implement performance contracts and succession plans
• Manage conflict, disciplinary and safety issues
• Assist with recruitment
• Release Starting Materials, Packaging Materials, Consumables, Intermediate, Bulk and Finished Products
• Lot release and/or rejection of starting materials, packaging materials, consumables, components, intermediate, bulk and finished goods
• Approve compliance of QC laboratory preparation and testing activities to GMP, quality standards and product specifications
• Ensure all testing is carried out as agreed / scheduled
• Ensure laboratory outputs meet the agreed standard

Approve Specifications, Sampling Instructions, Test Methods, other QC Procedure and Validation Documents

• Review and approve the documents to comply with technical, GMP and Data Integrity requirements

Analytical Method Validation and Analytical Method Transfer

• Take the lead and ensue the relevant value stream laboratory AMT activities are executed
• Manage the method transfer activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications
• Provide scientific and technical expertise and manage communication with Analytical Method Transfer partners

Governance, Risk, Compliance to QMS and keep unit compliant to cGMP guidelines

• Ensure unit’s activities comply with current operating guidelines and policies for the organisation and function
• Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QC activities
• Ensue that appropriate validations are completed as per validation requirements and schedule
• Initiate and set targets and review GMP, quality and training needs