Syngene International looking for Senior Manager
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Senior Manager (4870)
Job Description
• Ensure organizational compliance with corporate information security policy, procedures, applicable laws and regulations by conducting audits and monitoring.
• Ensure 21 CFR Part 11 , Annex 11 and predicate rules of GXP (GMP, GCP, GLP) and DI compliance
• Ensure compliance in Computer System Validation (CSV) and GAMP 5(Good Automated Manufacturing Practice) guidelines.
• Drafting policies and procedures for corporate quality/IT function.
• Develop a compliance verification system in IT/CSV /Automated Process activities as part of Corporate Quality
• Integrate the IT policies and procedures in line with the corporate quality management plan.
• Face regulatory audits, Client audits and conduct internal audits
• Support in Information Security Risk Management during execution of key projects and advice/develop on mitigation plans.
• Monitor implementation of action plans to ensure risk mitigation efforts are proceeding as required
• Design, Plan and drive information security awareness programs, trainings, induction sessions
• Liaise with department and BU heads on the adequacy of proposed actions in management of risk areas highlighted in internal & external audits
• Undertakes investigations of potential compliance issues in Information security and data management
• Implement the best practice of ISO 27001 requirements as Corporate quality initiative of continual improvement
• Data backup administration
Secondary Responsibilities:
• Understand the complexities of procedures and regulations in Pharmaceutical/Healthcare industries and advise on the needed changes in the compliance monitoring
• Work within an interdisciplinary research and manufacturing team and support in resolving compliance issues
• With effective communication Presentation, inter-personal Skills build network among the different vertical/BUs and coordinate with them as face of CQRC.
• Execute strategic plans for CQRC
• Training: Identify training needs from audit experience and participate in group discussions, seminars, workshops etc
Additional Information
Qualification : M.Pharm, M.Sc
Location : India
Experience : 3-6 Years
Industry Type : Pharma
End Date : 20th July, 2019
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