Product Release Leader

About the role

To provide operational quality support and oversight to all GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas. Ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes.

Responsibilities

• Review and release products that are manufactured and/or packaged in compliance with local and regulatory requirements
• Improve the effectiveness of quality in preventing /identifying and addressing quality issues by enabling a strong quality culture and leading continuous improvement efforts
• Maintain presence and be accountable for quality decision-making and quality escalations to all GMP operational areas
• Provide quality oversight for GMP areas including Oral Solid Dose, Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas
• Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues
• Accountable for quality decision making via work order assessments, atypical comments, and initial impact assessment for deviations
• Responsible for review, release and second check of batch record documentation for compliance to cGMPs, SOPs, and internal and regulatory requirements
• Ensure that all GMP documentation and records follow Good Documentation Practice (GDP) by adhering to ALCOA++ principles for data integrity through both review and end-user support
• Provide timely guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects
• Support and/or lead problem solving / root cause analysis and CAPA identification
• Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities
• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support and/or lead continuous improvement efforts
• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions
• Role model the GPS standards and foster a Quality Starts with Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety
• Communicate effectively with team members, escalate issues to production and quality team/lead and provide on call support as required
• Create, review and second check certificates (CoA, CoC) in alignment with market requirements and GSK standards

Qualifications

• Bachelor’s Degree and 4+ years of GMP pharmaceutical experience
• 4+ years of Pharmaceutical Manufacturing, Quality, QC experience or similar and able to apply Quality Management Systems (QMS) and GMP principles to day-to-day role
• Experience working with quality systems such as deviations, CAPA, change control, and document control