Manager - Testing

Our client is an American multinational pharmaceutical and biotechnology corporation.

• Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.
• Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.
• Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.
• Collaborate with site functional areas and customers to support site goals, objectives and timelines.
• Ensure alignment to all regulations and Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.
• Provide oversight of Microbiology product testing group responsible for routine testing of product or process samples for endotoxin and bioburden.
• Oversee project management of all Data Integrity related activities with the relevant teams.
• Address and resolve any potential issues with regulatory impact.
• Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.
• Represent area of responsibility at meetings and in audits.
• Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.
• Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.

• Demonstrated experience in Quality Control
• Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
• In-depth understanding of aseptic processing and monitoring procedures
• Reasoning ability including strong analytical and problem solving abilities
• Strong people management experience
• Strong verbal and written communication skills
• Hands on experience in BET, Bioburden, sterility, Method validations
• Work allocation to the team & make sure that the analysis completed on time
• Resolve the issues raised by the analyst in day to day activities
• Review and approval of analytical protocols & reports
• Conduct Tier 1 IMEx meeting and escalate the issue on time to the management
• Monitor the performance of the team members
• Should face National & international audits like USFDA, MHRA & TGA.

Nice-to-Have
• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Location- Vizag