Salary Between 15-20 Lacs Manufacturing Oversight: Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements. Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release. Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site. Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards. Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams. Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance. Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting. Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence. Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures. Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements. Participate in virtual inspections and audits, providing requested documentation and clarifications. Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues. Provide remote guidance to manufacturing site teams through virtual meetings, calls, and written communication. 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. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
Salary Between 15-20 Lacs QA-Validation – Sterile Injectables (Candidate with B1/B2 USA Visa Preferred) Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Validation Activities: Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity. Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site. Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment. Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented. Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation. Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover. Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality. Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs 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. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
QA-Compliance – Sterile Injectables Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes. Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance. Handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements. Review, approve, and trend deviations for recurrence patterns and systemic issues; prepare periodic deviation trend analysis reports for management. Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines. Review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance. Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements. Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports. Handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments. Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence. Monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports for management. 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. Education and Qualifications: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.