Silva Pharmaceuticals Limited Job Circular

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Post Name: Deputy/ Quality Assurance Manager

Published on: 10 Jan, 2022

Application Deadline: 9 Feb 2022

Vacancy: N/A

Description

• To manage, co-ordinate and direct all the activities of Quality Assurance department
• To lead the Quality Assurance team to assure Quality of Products manufactured at plant.
• To lead and manage all aspects of Operational Quality, Validation, Regulatory and Technical Support and Quality Assurance services.
• Promote Quality compliance and Quality Management System (QMS).
• Take overall responsibility of Product release to market Quality Compliance, Quality Council, Technology Transfer.
• Take responsibility for Audit & Inspection of manufacturing & supply units and to attend regulatory audits & Inspections by Internal and external bodies and lead the compliance.
• Lead a team of Qualified Persons (QP) ensuring training & development of quality professionals ensuring a robust talent development and succession plan.
• Ensure that Quality Risks are proactively managed.
• Create a healthy & safe environment to work and ensure that all the EHS standards are understood and applied.
• Maintain liaison with the government & non government’s agencies.
• Lead New Technology Transfer products to be introduced to fulfill commercial ambitions.
• Handle QMS documents like product complaint, deviation, change control, reprocess, repacking etc.
• Manage proper distribution and implementation of updated SOPs and other documents.
• Implement the retention sample management system.
• Review the batch documents for batch release.
• Independently manages review and approval of master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements.
• Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition.
• Leads, trains others and approves Quality investigations.
• Leads the review and approval of change control requests to ensure compliance with all applicable requirements.
• Independently initiates and approves SOP updates and creation of new SOPs. Additionally, oversees review of SOPs and associated documentation to ensure biennial review requirements are met.
• Lead establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan).
• Ensure that all quality and regulatory requirements (as per cGMPs, ICH and ISO 9001 standard) is effective, implemented and continuously improving for all products and processes.
• Develop and maintain internal audit program and standing systems, which deal with nonconforming product (NCR), customer inquires (CI), corrective and preventive actions (CAPA), track and monitor these actions until closure.
• Schedule and conduct Management Review Meeting as required by ISO 9001 standard.
• Additional duties as assigned.

Educational Qualification: