JOB DESCRIPTION
Designation: Associate Manager / Deputy Manager - IT - CSV
Job Location: Bengaluru, Karnataka, India
Department: IT - CSV
About Syngene:
Incorporated 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.
Job Purpose:
To perform support and supervise Computerized System Validation (CSV) for GxP systems
Key Responsibilities:
Responsible for ensuring the accuracy, completeness and compliance of validation deliverable by plan/ review/ train/ guide/ support of the validation packages of IT applications in a regulated industry.Responsible for the preparation, implementation, training and supporting the IT policies, protocols, procedures and standards, including but not limited to, project management, change management, internal & external compliance, and other documentations.Responsible for validation of regulated IT projects or platforms by planning validation deliverable, working on validation documentation, participating in authoring deliverable, functional requirements definition, trace ability matrix, validation protocol development, validation testing and deviation management; and working closely with cross- functional project teams.Provide support to IT project teams in validation compliance as per the procedures.Provide support / guidance to IT team on infrastructure qualification i.e. Desktops, servers, LAN, WAN & other computer Based systems impacting GxP at sites.Recommend and support on Corrective and Preventive Actions (CAPA) to improve the validation practices. Provide practical solutions to a wide range of difficult challenges in IT validation and provides advice to the project teams on validation.Coordinate with program/ project leadership, and other stakeholders and manage their expectations plans for validation for a project based on validation requirement, tracks and reports progress to project team on validation.Involved and support periodic review of application systems & IT infrastructure for maintaining their validated state as per procedure.Responsible for managing the internal, customer, and regulatory audits ensuring compliance with IT CSV procedures and applicable regulations. And responsible for providing support in preparing documentation for regulatory submissions and audits response if any.Guiding the IT team/users by contributing knowledge and experience to help them to develop their IT compliance, technical skills, functional knowledge and quality awareness.Educational Qualification:
Bachelors Degree in Computer, Science, Engineering Or Related Field, Or An Equivalent Combination Of Training.
Technical / Functional Skills:
Candidate should have knowledge of current regulatory & guidelines for CSV i.e. 21 CFR part 11 ERES, Part 820, part 210 & 211, EU annex 11, ichq9 and sop requirements of computerized systems.The candidate should have an extensive background in information technology and be experienced with supporting and/or managing it quality of computer systems/software validation delivery and oversight.Candidate should have strong understanding and working experience of assessing and remediation of computerized systems for electronic record & electronic signature(ERES) compliance (as per different pharma/life science regulatory requirements) mainly data security, traceability and integrity.Candidate should have good exposure to quality management systems compliance with all applicable healthcare laws and regulations with a focus on computer systems validation (csv).Candidate should have good understanding on GAMP 5 and have hands on experience on computer systems validation (csv) using v-modal.Candidate should have ability & knowledge to perform risk assessment and risk mitigation.Candidate should have good knowledge and understanding on GxP qc & manufacturing applications systems administration, enterprise application like LMS, Documentum sap validations, PLC and Scada systems validation, configuration & security policies implementation, audit trail review mechanism, privileges & roles management, user management (user creation, modify, activate, deactivate, disable, enable, role assignment etc.).Candidate must have knowledge of GxP systems data backup & restore strategy w.r.t. Pharma regulatory requirements.Ideally significant experience of cloud computing in a healthcare environment, computer systems validation within an agile environment and the GAMP 5 framework.Candidate should have experience of handling & managing internal, customer, and regulatory audits.GAMP 5 risk-based approach to computer system validation using V Model.Good exposure to Quality Management Systems(QMS) and handling Audits both Internal & External.Experience:
- 5-9 Years with Minimum 4+ Years In Pharmaceutical / Life Science In CSV Domain
- Strong working experience and knowledge of current regulatory & Guidelines for CSV i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems.
Behavioral Skills:
- Excellent written and verbal communication skills.
- Creative thinking and problem-solving skills
- High degree of flexibility in terms of working hours
- Must maintain a culture of inclusiveness and integrity
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
