ITQA Specialist

Designation: Assistant Manager
Job Location: Bangalore
Department: Corporate Quality Assurance

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 Specialist

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 IT related documents as applicable. Review/Approval of Software Validation Deliverables for CSV compliance per regulatory guidelines (21 CFR part 11, EU Annex 11, GAMP 5 etc). Collaborate with IT and CFT teams to ensure GxP data compliance during system upgrades, Software Qualification, and strategic initiatives. Ensure consistent compliance during review and approving of GxP IT Systems document with regulatory requirements. Handle QMS activities such as Deviation, Change Control, CAPA etc. Perform GxP computerized systems assessments and ensure adequate security controls. Coordinate and participate in audits (internal, client, regulatory). Verify IT compliance, identify gaps, and mitigate IT system risks. Prepare management reports for ITQA projects and quality reviews. Communicate promptly and effectively with the clients and CFT members.

Key Responsibilities:

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 safety policies, procedures, and requirements, identifying causes of non-compliance. Ensure compliance with SOPs and assess SOP verses practices and identify non-compliance. Review and approval of SOPs, Protocols, Schedules, and other IT related documents as applicable. Ensure compliance with SOPs and approved instructions and identify the cause of non- compliance. Ensure compliance of computerized systems validation data during GxP system upgrades and strategic initiatives. Review/Approval of Software Validation Deliverables for CSV compliance per regulatory guidelines (21 CFR part 11, EU Annex 11, GAMP 5 etc). Collaborate with IT and CFT teams to ensure GxP data compliance during system upgrades, Software Qualification, and strategic initiatives. Ensure consistent compliance during review and approving of GxP IT Systems document with regulatory requirements. Handle QMS activities such as Deviation, Change Control, CAPA etc. Perform assessments of GxP computerized systems and ensure adequate security controls. Coordinate and participate in audits (internal, client, regulatory). Verify IT compliance, identify gaps, and mitigate IT system risks. Prepare management reports for ITQA projects and quality reviews. Communicate promptly and effectively with the 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.

Experience Required:

9 to 12 years of experience in IT quality function within the pharmaceutical/IT industry.

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 a team.

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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