Title: ITQA and CSV Compliance Specialist
JOB DESCRIPTION
Designation: Junior Manager
Job Location: Bangalore
Department: Corporate Quality Assurance – ITQA
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:
ITQA and CSV Compliance Specialist
Job Description:
- System Management and handling Enhancements:
- Ensure compliance with Data integrity policy and identify the cause of non-compliance.
- Act as validation engineer during system upgrades and strategic initiatives.
- Conduct regular system hygiene checks to identify system gaps, and feasibility checks for process improvements.
- Coordinate with IT-SME or service providers to streamline workflows and enhance ERP systems such as Trackwise workflows, Data fields, Trackwise web services, Query management and its functionalities.
- Validation Deliverables Documentation and Reporting:
- Prepare and review Software Validation Deliverables to comply with CSV aspects per regulatory guidelines (21 CFR part 11, EU Annex 11, and GAMP5).
- Update project status reports for internal Quality review meetings.
- Review of Quality agreement as applicable. Maintain the list of Validation data.
- Training and System Owner Support:
- Provide training and support to end-users on System functionalities, best practices, and compliance.
- Manage User Access and address user concerns related to Documentum processes.
- Communicate promptly and effectively with the clients and CFT members.
- System Compliance:
- Handle Change Control, Deviation, CAPA, and Audit management related to the ERP systems.
- Review the requalification status and update the CSV applications list periodically.
- Able to review and Crystal reports, Configuration and build reports, history reports, etc.
- Provide timely compliance to the audit observation and track the proposed CAPA
- Ensure compliance with SOPs and approved instructions and identify the cause of non-compliance.
- Review of investigation, provide inputs in the identification of root cause, and propose the CAPA for the identified CAPA.
Key Responsibilities:
- Ensure compliance with safety policies, procedures, and requirements, identifying causes of non-compliance.
- Ensure compliance with Data Integrity Policy, identifying causes of non-compliance.
- Ensure compliance with SOPs and approved instructions, identifying causes of non-compliance.
- Act as a validation engineer during system upgrades and strategic initiatives.
- Conduct regular system hygiene checks, identifying system gaps and feasibility for process improvements.
- Coordinate with IT-SMEs or service providers to streamline workflows and enhance EQMS Trackwise functionalities.
- Prepare and review Software Validation Deliverables to comply with regulatory guidelines.
- Update project status reports for internal Quality review meetings.
- Provide training and support to end-users on EQMS functionalities, best practices, and compliance.
- Manage User Access and address user concerns related to Documentum processes.
- Handle Change Control, Deviation, CAPA, and Audit management related to the EQMS Trackwise system.
- Review the requalification status and update the CSV applications list periodically.
- Ensure overall adherence to safe practices and procedures for oneself and aligned teams.
- Manage vendor qualifications, review quality agreements, and maintain validation data.
- Coordinate system upgrades and enhancements and prepare and review validation documentation.
Educational Qualification: M.Sc./Pharmacy
Technical/Functional Skills:
Good communication skills and experience in pharma industry.
Experience: 05 to 10 Years
Behavioral Skills:
• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• 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 able to work in team and flexible for working in shifts.
• 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.