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Executive - Production Documentation

Executive - Production Documentation

Biocon

3 - 7 years

0 Lacs

andhra pradesh

Posted:6 days ago| Platform: Shine logo

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Skills Required

sops bmr aim hazop study validation standard operating procedures qms activities eops ocps batch reports productivity improvements batch failure investigations hira register coordination with qa qualification audit preparedness product specifications good manufacturing practices good documentation practices quality records

Work Mode

On-site

Job Type

Full Time

Job Description

As a candidate for this role, you will be responsible for handling various Quality Management System (QMS) activities such as managing Corrective and Preventive Actions (CCF), deviations, and Out of Specification (OOS) incidents. Your duties will include preparing and reviewing Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operating Control Plans (OCPs), Batch Manufacturing Records (BMR), and other production-related documents. Additionally, you will be required to review batch reports, participate in productivity improvement initiatives, and investigate batch failures. You will also be responsible for creating and maintaining the Asset Integrity Management (AIM) and Hazard Identification and Risk Assessment (HIRA) register, as well as conducting Hazard and Operability (HAZOP) studies. In this role, you will collaborate closely with the Quality Assurance (QA) team to ensure validation, qualification, and audit readiness. It is essential to strictly adhere to Standard Operating Procedures, product specifications, Good Manufacturing Practices, and Good Documentation Practices. You will be responsible for reviewing all completed documents to ensure completeness and proper sign-off, as well as accurate data entry in Quality records. The ideal candidate for this position should have a Bachelor's (BSc) or Master's (MSc) degree and possess 3 to 4 years of relevant experience in a similar role.,

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Executive - Production Documentation