Opportunity for M.Pharm or B.Pharm as Assistant Manager at Syngene International

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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.

Post : Assistant Manager - Corporate Quality Assurance

Job Description
Primary Job Responsibilities
• Ensure organizational IT compliance with corporate policy, procedures, applicable laws and regulations by supporting audits and monitoring.
• Ensure 21 CFR Part 11, Annex 11 and DI compliance through internal policies and procedures.
• Ensure compliance in Computer System Validation (CSV).
• Drafting policies and procedures for Corporate quality/IT function.
• Develop a compliance Strategy for IT/CSV /Automated Process verification 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 support internal audits.
• Participating in Functional Risk Assessment during execution of Computer System Validation projects to advice/develop on mitigation plans.
• Monitor implementation of action plans to ensure risk mitigation efforts are proceeding as required.
• Liaise with department and BU heads on the adequacy of proposed actions in management of risk areas highlighted in internal & external audits.
• Support investigations for potential compliance issues in Information security and data management.
• Implement the best practice of part 11 requirements as Corporate quality initiative of continual improvement.
• 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 from ITQA front.
• Training: Identify training needs from audit experience and participate in group discussions, seminars, workshops etc.
• Execute defined strategic plans.
• Any other tasks assigned by the manager time to time.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company.

Candidate Profile
• Diploma/ BE/ BCA/ B Sc / M.Sc (Computer Science)/ B. Pharm/ M. Pharm
• Functional and Administration exposure in Enterprise Applications (like SAP, Learning Management System, Trackwise, Document Management System) and Analytical & Manufacturing Process Applications like Chromatography Data Management system (CDMS), Lab Solutions, Particle Analyzer, Instrument calibration and maintenance system (ICMS), Distributed Control System (DCS,) Supervisory Control and Data acquisition system (SCADA).
• Exposure to Part 11, GAMP 5, Annexure 11 and CSV flow.
• Compliance experience on IT enabled services.
• Life Science QMS procedures.
• Computer System Validation (CSV) deliverable preparation / review.
• Establish good Interpersonal skills with cross functional teams.
• Should have good communication skill and should be a good team player.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be a focused employee.

Additional Information
Qualification :
M.Pharm or B.Pharm, B.Sc, M.Sc
Experience : 8-10 years

Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Req Id : 11997
End Date : 30th July, 2020


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