API - Production
Biocon Limited
1 Years - 6 Years
As per industry standard
Visakhapatnam, Hyderabad
Job Description
Roles and Responsibilities
Key Responsibilities:
- Carry out shift operations ( Unit operation like Operating Reactors, centrifuges ,clean room equipments etc, Hydrogenation, handling Nbl reaction etc)
- Adherence to Safety, Health and Environment measures.
- Reporting of non-conformities and adherence to the corrective / preventive actions in specific areas of operation.
- Authorized to raise Deviation Reports and Change Controls.
- Co-ordination with QA for line clearance during product change over.
- Authorized to prepare, issue and review quality documents (authorized person from next senior level).
- Maintenance of production related documents and quality records.
- Initiation of corrective and preventive actions against non-conformance.
- Overall coordination with other departments related to production activities.
- Adherence to Quality Policy and Quality Management System.
- To coordinate with QA for all the validation, qualification and Audit preparedness
- Calibration of weighing instruments in production.
- Adherence to and creating awareness about Standard Operating Procedures and product specifications.
- Finished product quarantine/inspection/packaging/storage.
- To monitor housekeeping
- To perform equipment cleaning.
- In-process product sampling, inspection and storage.
- Data entry in Quality records.
- Adherence to Good manufacturing practices.
- Adherence to cGMP.
- Reporting of product/system non-conformities, and implementation of corrective/ preventive actions in specific areas of operation.
- Preparation of SOP’s, ECC's, EOP's, Checklists and Log sheets (Authorized person by Department Head.)
Technical/Functional Skills:
- Good knowledge on centrifuge, reactors, filters pumps, techniques & aseptic operations.
- Should have experience in Current Good manufacturing practices. (cGMP)
- Good documentation skills
- Awareness of audit requirements.
- Knowledge of documentation for USFDA & EU ,ability to troubleshoot problems.
Desired Candidate Profile
Qualification: B. Sc - Chemistry/Diploma - Chemical Engineering
Experience: 1 to 6 years
Job Information
- Job Type: Full Time
- Industry: Biotechnology/Pharmaceutical/Medicine
- Function : Bio Tech/R&D/Scientist
- Specilizations: Medical Representative
- Qulification: B.Sc, BE/B.Tech, Diploma
- Key Skills: Api Production ProductionManufacturing
About Company
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Biocon Limited
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Biocon: Enhancing Global Healthcare Biocon Limited, publicly listed in 2004, is India's largest and fully-integrated, innovation-led biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving customers in over 120 countries. Driven by a vision to enhance global healthcare through innovative and affordable biopharmaceuticals, we have enabled access to advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. The early anticipation of the increasing dominance of biologics in global development pipelines helped us to be ahead of the curve in crafting a differentiated product portfolio based on fermentation and recombinant technologies, which straddles fermentation-derived small molecules and biologics, both novel as well as biosimilars. The significant brand equity that we have built worldwide for our small molecule APIs across statins, immunosuppresants and other specialty products has made us a leading global supplier of these products. We have also built one of the largest and most diverse biosimilar pipelines, spanning insulins, monoclonal antibodies and other recombinant proteins that address critical chronic diseases such as diabetes, cancer and autoimmune disorders. Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in volume terms, we are the first Indian company to launch a biosimilar in Japan with Insulin Glargine, which also has been approved for sale in EU and Australia. Our insulin products have made a difference to the lives of millions of people with diabetes across the globe. We now aim to provide our insulin products to one in five’ people with diabetes in need of insulin-based therapy anywhere in the world within the next 10 years. We are also making a huge impact in the area of cancer care. Our biosimilar Trastuzumab, which was the first to be approved anywhere in the world and launched in India in 2014, has helped treat several thousand HER2-positive metastatic breast cancer patients. We are also the first company from India to get its biosimilar approved by the USFDA; Ogivri™, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition to Trastuzumab, several of our biosimilar assets are on track for anticipated regulatory approvals in developed markets. We are also developing a pipeline of patented biologics to address global unmet medical needs. We have successfully launched a couple of novel biologics in India: Nimotuzumab for the treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, we have a basket of novel assets are under various stages of clinical development, including a high potential oral insulin. Through our subsidiary, Syngene, we offer a suite of integrated, end-to-end discovery and development services for novel molecular entities (NMEs) to the global life sciences sector. Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance access to life-saving therapies and make a significant impact to global healthcare through ‘blockbuster’ drugs with the potential to benefit a billion patients.