Investigation Manager – Microbiology
In your role, you will help us in investigation of any quality issues in manufacturing and quality laboratories. You will work with a team to investigate deviations and out-of-specification results and atypical result investigations. Your problem-solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.
As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It
Manage multiple projects / ongoing work activities within the department typically involving cross-functional representatives.
Evaluate policies and procedures are developed, maintained in accordance with Corporate and regulatory requirements.
Collaborate with cross functional teams, perform and document investigations regarding Manufacturing incidents.
Investigate, identify root cause and preventative measures using DMAIC approach and other appropriate tools.
Analyzethe information using different statistical tools.
Design studies as needed to gather critical data for investigations and/or corrective actions.
Coordinate and direct product disposition in accordance to agreed plan with Management.
Identify and implement corrective and preventive actions (CAPA) to eliminate the potential for non-conformities to occur. Perform effectiveness checks for investigations.
Track, trend, and act in a systematic and effective way to assure timely closure.
Identify opportunities for improvement through investigations; and implement them via simplification projects and quality system tools.
Provide training and guidance to manufacturing investigators to promote consistency in investigation practices.
Coach and develop colleagues in investigation skills and provide guidance to team members in critical investigations.
Develop the team capability and skills through continuous support and one on one coaching.
Review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected GXP standards.
Master’s Degree and 10+ years of experience.
People Management experience.
Experience in handling of investigations through Quality Tracking system.
GMP Manufacturing and QA/QC Laboratory environment experience.
Project Management experience.
Strong interpersonal and influential skills.
Exposure of USFDA, MHRA & TGA
Broad experience and knowledge in all areas of biologic manufacturing, including cell culture, fermentation, purification, microbiology and chemistry.
Strong understanding of DMAIC methodology and Method 1 coaching training, or similar.
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