Executive - Production Documentation Biocon

3.0 - 7.0 years

0 Lacs

andhra pradesh

On-site

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.,

Posted 3 days ago

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Assistant Manager Syngene International Limited

10.0 - 15.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Manufacturing Services Designation: Assistant Manager Job Location: Bangalore Reporting to: Deputy Manager Job Grade: 8-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngenes 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific Provide input to Downstream for improvement of products/process. Develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders within the department. Downstream batch plan preparation as per campaign schedule. Supervise commissioning and qualification activity of BMP1 DSP related equipment. Preparation of micro batch schedule and shift planning for day-to-day activities. Monitor and follow good aseptic behavior inside the BMP1 facility. Support in audit and audit closure points. Involve in shipment of samples / final product as per packing and dispatch record. Preparation of BMRs, SOPs,IOPs & EOPs,general validation protocols and reports, equipment requalification protocols, Installation, operation and performance qualification protocols and related documents. Supervise Downstream activities of buffers preparation, Harvest, purification and final filtration, Calibration of operations equipment. Monitoring and process control of specific operations of downstream. Compliance to current good manufacturing practices. Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required. Perform room owner responsibility for the assigned DSP area. Maintain facility and assigned zone all-time ready for visit and audit. Involve in Shipment of samples /final product as per packing and dispatch record. Review of executed Documents on time. Education and Experience Education Graduate or Masters degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 10 - 15 years of relevant practical experience in Downstream process Production for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc. Other Competencies Required For The Role NA Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less

Posted 1 week ago

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