102 Microbiology Jobs in New Delhi

• 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.