GxP Systems Validation Compliance Specialist

4 weeks ago

bangalore, India Syngene Full time

JOB DESCRIPTION
 

Designation:  Assistant 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:
GxP Systems Validation Compliance Specialist - ITQA

Job Description:

Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non- compliance. Ensure compliance with Data integrity policy and identify the cause of non-compliance. Ensure compliance with the safety policy. procedures, and stated requirements and identify the cause of non-compliance. Ensure compliance with SOPs and approved instructions and identify the cause of non- compliance. Review and approval of SOPs, protocols, schedules, and other related documents as applicable. Review Software Validation Deliverables for CSV compliance per regulatory guidelines (21 CFR part 11, EU Annex 11, GAMP etc). Collaborate with IT and CFT teams to ensure GxP data compliance during system upgrades and strategic initiatives. Conduct regular SOP version verification, system hygiene checks, Audit trail review. Coordinate with core teams to implement digitization projects (e.g., Trackwise, EDMS, LIMS, SAP, LIMS, CDS systems) for CSV progress. Ensure consistent compliance of GxP IT Systems with regulatory requirements. Monitor quality operations compliance, and handle QMS activities such as Investigations, Change Control, CAPA, and documentation. Perform GxP computerized systems assessments and ensure adequate security controls. Create, revise, and review procedures and protocols for IT system digitization projects. Coordinate and participate in audits (internal, client, regulatory) and provide CAPA responses as needed. Verify IT compliance, identify gaps, and mitigate IT system risks. Prepare management reports for digitization projects and quality reviews. Review of Management Information system reports. Communicate promptly and effectively with the clients and CFT members. Ensure training completion before startup of assigned activities.

Key Responsibilities:

Ensure compliance with safety policies, procedures, and requirements, identifying causes of non-compliance. Ensure compliance with Data integrity policy and identify the cause of non-compliance. Ensure compliance with SOPs and assess SOP verses practices and identify non-compliance. Review and approve SOPs, protocols, schedules, and related documents as applicable. Ensure compliance of computerized systems validation data during GxP system upgrades and strategic initiatives. Review Software Validation Deliverables for CSV compliance according to regulatory guidelines (21 CFR part 11, EU Annex 11, GAMP, etc.). Conduct regular verification of SOP versions, system hygiene checks, and Audit trail reviews. Coordinate with core teams to implement digitization projects for CSV progress (e.g., Trackwise, EDMS, LIMS, SAP, CDS systems). Ensure consistent compliance of GxP IT Systems with regulatory requirements. Monitor compliance of quality operations and manage QMS activities such as Investigations, Change Control, CAPA, and documentation. Perform assessments of GxP computerized systems and ensure adequate security controls. Create, revise, and review procedures and protocols for IT system digitization projects. Coordinate and participate in audits (internal, client, regulatory) and provide CAPA responses as needed. Verify IT compliance, identify gaps, and mitigate IT system risks. Prepare management reports for digitization projects and quality reviews. Review Management Information system reports. Communicate promptly and effectively with clients and CFT members.

Educational Qualification:   M.Sc /M. Pharmacy

Technical/functional Skills:
• Good communication skills and experience in Pharma industry., familiar with Software Validation Deliverables for CSV compliance according to regulatory guidelines and hands on experience on GxP systems 


Behavioural 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.

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