In-Process Quality Assurance (IPQA) Specialist (Sterile Injectables)

Key Responsibility:

Manufacturing Oversight:

Shop Floor Oversight:

• Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements
• Provide real-time guidance and decision-making during production to ensure product quality and compliance

Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)

• Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures
• Ensure completeness, accuracy, and timely review of all manufacturing records

In-Process Quality Checks:

• Perform in-process quality checks during manufacturing stages to ensure critical process parameters and product specifications are met
• Review and verify product labels for accuracy, ensuring they meet regulatory standards and internal quality requirements
• Document results and address deviations immediately to avoid process interruptions

Line Clearance:

• Conduct line clearance at critical manufacturing stages, ensuring equipment, materials, and personnel comply with procedural and environmental requirements

Annual Product Quality Review (APQR)

• Compile and analyze data for APQR, ensuring thorough review and identification of trends
• Collaborate with cross-functional teams to implement improvements and corrective actions based on APQR findings

Quality Management System (QMS):

Change Control:

• Review and approve change control proposals.
• Assess the impact of changes on validation and regulatory compliance.

Deviation Management:

• Investigate deviations, identify root causes, and implement corrective actions.
• Document and trend deviations to monitor quality improvements.

CAPA (Corrective and Preventive Action):

• Develop and implement CAPAs for identified issues.
• Track and verify CAPA effectiveness within the specified timeline.

Out-of-Specification (OOS) and Investigations:

• Manage OOS, OOT and conduct thorough investigations, and prepare investigation reports.
• Implement corrective actions to prevent recurrence.

Regulatory Compliance:

• Ensure adherence to cGMP, US FDA and other regulatory requirements.
• Participate in internal and external audits and inspections.

Mandatory Requirements:

• Valid B1/B2 Visa for the USA.
• Willingness to travel for work, including international travel to the USA and other regions as required.
• Have to work as per US timings when working remotely.

Key Skills and Competencies:

• In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Ability to manage cross-functional teams and prioritize tasks.
• Proficiency in QMS tools and software.