Manager- Quality (DDRC) - Vendor Management

Job Description

The role involves managing vendor qualifications remotely and ensuring the timely exchange of relevant documentation to support API production. Additionally, the position includes reviewing QA-related manufacturing and maintenance documentation to ensure compliance with regulatory standards. KEY STAKEHOLDERS: INTERNAL - Site Quality Team (QC, QA), Corporate Functions QUALIFICATION: B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology EXPERIENCE: Need to be ready to live and embrace the Piramal values. Quality professional with 8+ years of QC / QA experience in a regulated pharma companies. Must have hands-on experience in Vendor management Experience in qualifying and re-qualifying vendors, ensuring compliance with regulatory standards. Ability to manage vendor relationships, resolve issues, and track vendor performance metrics. Familiarity with conducting vendor audits and maintaining qualification documentation. Proficient in using vendor management software and coordinating documentation exchanges with vendors. Experience reviewing QA-related manufacturing and maintenance documentation for compliance. Knowledge of regulatory requirements (eg, FDA, GMP) for documentation management. Expertise in assessing and ensuring accuracy of production logs, calibration, and PM reports. Experience collaborating with internal teams to address discrepancies in QA documentation. Knowledge of applicable regulatory requirements / regulations (USFDA, EU, Health Canada, others). we'll-organized and committed, with strong verbal and written communication skills. Good Collaboration skills and Team player. KEY ROLES/RESPONSIBILITIES: Vendor Management: Qualify or re-qualify vendors that supply materials for API production, ensuring compliance with industry standards. Maintain and update the vendor qualification data and related documentation in the system. Communicate with vendors for the submission and receipt of qualification documents. Coordinate with internal departments to ensure that vendor performance meets production requirements. Conduct regular audits of vendors to assess compliance with quality and safety standards. Ensure timely resolution of any issues or discrepancies between vendors and the company. Provide feedback to vendors to improve the quality and efficiency of supplied materials. Track vendor performance metrics and provide reports for review by management. QA Documentation Review: Review QA-related manufacturing documentation, such as batch records, production logs, and related reports. Assess maintenance documentation including preventive maintenance (PM) reports and calibration records. Ensure that all documents are complete, accurate, and comply with regulatory requirements. Collaborate with the QA team to address discrepancies or gaps in documentation. Monitor compliance with internal and external quality standards through document review. Assist in the preparation of quality reports and audits based on document reviews. Support the QA team in identifying areas for improvement in manufacturing processes and documentation. General Responsibilities: Assist in the development and implementation of standard operating procedures (SOPs) for vendor management and documentation review. Participate in meetings and discussions to improve overall supply chain efficiency and vendor relations. Provide support during regulatory inspections or audits, ensuring that all documentation is up to date and available. Coordinate with the production and maintenance teams to ensure timely completion of qualification processes and document reviews. Contribute to continuous improvement initiatives within the vendor management and quality assurance processes.