Assistant Manager - Corporate Quality Assurance (ITQA)

Job Description

Designation: AssistantManagerJob Location: BangaloreDepartment: Corporate Quality AssuranceAbout SyngeneIncorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Key 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.

Educational Qualification: Diploma/ BE/ BCA/ BSc/ M.Sc (Computer Science)/ B. Pharm/ M. Pharm / MCATechnical/functional Skills:

• 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.

Experience: 9-12 yearsBehavioral Skills:

• 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.

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.,

Keyskills :
animal healthit compliancerisk mitigationcontrol systembanking21 cfrdata acquisitiondata managementtraining needsequal employment opportunitysalestatenvironmental impact assessmentmiscontinuous improvement facilitationcomputer system valida