QA Supervisor (QC)

Job content

The incumbent will ensure that the quality systems, the products manufactured, and Good Manufacturing Practice (GMP)

related operations observe consistent compliance with cGMP, site Standard

Operating Procedures (SOPs), and regulatory guidance.

Work across all site functions related to Laboratory Qualification,

Computer System Validation, Cleaning Validation, Process Validation, and Facility, Utilities and Manufacturing Equipment Qualification activities.

The incumbent will have an excellent knowledge of cGMP, cGLP, cGAMP, and knowledge of the associated validation principles. The incumbent will be required to develop strategic and system action plans by conducting hazard analyses, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures.

The incumbent will lead a team of QA professionals and will need to be action-orientated and a strong leader for the quality culture of the site.

Responsibilities:

• Lead and supervise QA Specialists for QC lab support end to end activities.
• Support reporting manager’s objectives, priorities, and metrics for the team.
• Review and approve laboratory investigations and QC deviations and change controls when and where required.
• Review and approve QC testing specification, QC testing methods, procedures, operational instructions, change controls, deviations, stability reports etc. as and when required.
• Review and approve raw material reduce testing program
• Ensure and provide guidance to QC team on company internal standards and all pharmacopoeia requirements are adhered during reviews and approvals.
• Conduct training(s) to increase knowledge and understanding of regulatory requirements, PQS, Good Manufacturing
• Practices (GMP) requirements and ALCOA with the team and to QC team.
• Participate and lead site teams/projects e.g., Safety, continuous improvement, manufacturing support and QA Oversight
• Work closely with Quality Operation, Production, Engineering, Warehouse and Supply chain personnel to support them in QA oversight, supply demand planning and system troubleshooting when required.
• Update and optimize QA team resources and capacity utilization.
• Develop the skills and capabilities of QA Specialists.
• Stand in for the QA Manager in his/her absence
• Engage and inspire the team on performance expectations and coach the team to meet those expectations
• Focus on Safety and GMP Compliance
• Be accountable for the Good Data Management and Data integrity principles (ALCOA) and team performance
• Lead and support continuous improvement efforts, as applicable

Job Related Requirements:

• Demonstrated record of successful interaction with global regulatory agencies (e.g., FDA, HSA, MHRA) and other internal and external auditing groups.
• Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.
• Thorough knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.
• Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products.
• Excellent verbal, written and interpersonal communication skills.
• Demonstrated ability to interact effectively with senior management, auditors, and regulators.