Manager - Validation QA Amneal Pharmaceuticals

1.0 - 15.0 years

0 Lacs

gujarat

On-site

You will be responsible for preparing and reviewing the Validation Master Plan (VMP) in alignment with the site's validation strategy and regulatory requirements. This includes monitoring and reviewing qualifications of equipment, systems, and utilities such as HVAC, purified water, and compressed air systems. You will oversee process validation activities, including protocol preparation, execution, data compilation, and report finalization. Additionally, you will review validation protocols and reports for various systems and ensure validation lifecycle management and periodic re-validation as per the established schedule. Furthermore, you will be responsible for initiating and reviewing change controls, deviations, and CAPAs related to validation activities. In case of failure investigations, you will conduct and support them, implementing robust corrective and preventive actions. It is crucial to adhere to regulatory expectations (USFDA, EU, WHO, etc.) in all validation activities and maintain validation documentation as per data integrity and Good Documentation Practices (GDP). Timely execution and review of cleaning validation and verification activities are also part of your responsibilities. Participating in risk assessments (FMEA, HAZOP), quality risk management related to validation, and providing training on validation concepts and GMP requirements to QA and production personnel are important aspects of the role. Collaboration with cross-functional teams (Engineering, Production, QC, IT) to ensure validation readiness and participation in audits as a validation SME will be required. In terms of additional responsibilities, you will ensure the timely review of protocols and reports related to new equipment, software, or process changes. Supporting technology transfer, new product introduction (NPI), and the qualification of laboratory instruments and computerized systems (CSV) are also part of your duties. Implementing and monitoring continuous improvement initiatives within the validation domain is expected, along with driving audit preparedness and supporting the creation and revision of validation-related SOPs. As a senior member of the team, you will act as a mentor and guide for junior validation staff, ensuring timely tracking and closure of validation-related quality events in QMS. Establishing and monitoring key performance indicators (KPIs) for validation activities and collaborating with corporate validation and regulatory teams for updates and global alignment are also essential aspects of the role. Qualifications: - Education: M.Sc. Chemistry (Preferred), B. Pharm (Required), M. Pharm (Preferred) - Experience: 10 to 15 years of relevant experience in Validation QA in pharmaceutical/API/Formulation manufacturing, minimum 1 year in the current role - Skills: Validation Master Planning, Equipment/Utility Qualification, Process/Cleaning Validation, Deviation & CAPA Handling, Change Control Management, Knowledge of HVAC, Water & Utility Systems, Current Regulatory Expectations, Failure Investigation & Root Cause Analysis, Documentation Review & Audit Preparation, Cross-functional Collaboration & Team Leadership.,

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