Skip to main content

Syngene International looking for Senior Manager

 

Clinical courses

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

APPLY ONLINE>>

See All  Syngene Jobs M.Pharm Alerts    Ph.D Alerts   Bangalore Alerts

See All   Other Jobs in our Database

Subscribe to Pharmatutor Job Alerts by Email