SME For Computer System Validation

Job Title: SME - Computer System Validation

Job Location: Bangalore

About Syngene :  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the role:

The core purpose of the role you described is as follows:

1. Ensure 21 CFR Part 11 compliance, EU Annex 11 compliance, and regulatory compliance: The primary objective of this role is to ensure compliance with regulatory requirements, specifically 21 CFR Part 11 and EU Annex 11. This involves understanding the regulations and implementing appropriate controls, processes, and documentation to ensure compliance. Additionally, staying updated with relevant regulations and monitoring changes to ensure ongoing compliance is also crucial.

2. GxP Computerized system validation (CSV) support for Manufacturing, QC, Enterprise applications: As part of this role, you will provide support and expertise in GxP computerized system validation. This includes validating and ensuring the compliance of various computerized systems used in manufacturing and quality control processes. Additionally, you will be involved in CSV activities for enterprise applications, ensuring they meet regulatory requirements and are validated properly.

3. Support new regulations and technologies like CSA, Agile, AI/ML, Cloud implementation in life sciences: Stay up to date with emerging regulations, technologies, and industry trends relevant to the life sciences field. Provide support in implementing and ensuring compliance with new regulations such as CSA (Cybersecurity Act), Agile methodologies, AI/ML (Artificial Intelligence/Machine Learning), and cloud implementations in life sciences. This involves understanding the impact of these regulations and technologies on IT systems and processes and ensuring proper compliance and implementation.

4. Coach the IT team on regulatory requirements for CSV/CSA and Data Integrity: Act as a coach and subject matter expert for the IT team, providing guidance and training on regulatory requirements related to computerized system validation (CSV), CSA, and data integrity. Help team members understand the importance of compliance and support them in implementing best practices and controls to maintain regulatory compliance.

By fulfilling these core purposes, candidate will contribute to maintaining regulatory compliance, ensuring proper validation of computerized systems, adopting new technologies, and promoting a culture of compliance within the IT team.

Role Accountabilities

The role accountabilities for the position are as follows:

1. Ensure the accuracy, completeness, and compliance of validation deliverables: Take responsibility for ensuring that validation packages for IT applications in a regulated industry are accurate, complete, and compliant. This involves planning, reviewing, training, guiding, and supporting the validation process to meet regulatory requirements.

2. Coach the IT team/users: Utilize your knowledge and experience to coach and mentor the IT team and users, assisting them in developing their IT computer system validation (CSV) and computer system assurance (CSA) skills, compliance knowledge, technical expertise, functional understanding, and quality awareness. Provide guidance and support to foster their professional growth and enhance their capabilities.

3. Ensure computerized system validation procedures align with regulatory expectations and technological advancements: Stay up to date with regulatory expectations and evolving technological landscape related to computerized system validation. Ensure that validation procedures are aligned with these requirements and address the latest technological advancements.

4. Provide support and guidance on infrastructure qualification: Offer support and guidance to the IT team on infrastructure qualification, including desktops, servers, LAN, WAN, and other computer-based systems that impact GxP (Good Practice) operations at various sites. Ensure that infrastructure components are properly qualified and meet regulatory standards.

5. Recommend and support corrective and preventive actions (CAPAs): Identify opportunities for improvement in the validation practices and recommend corrective and preventive actions (CAPAs). Provide practical solutions to complex challenges in IT validation and offer advice to project teams on validation strategies.

6. Maintain the validated state of application systems and IT infrastructure: Take responsibility for maintaining the validated state of application systems and IT infrastructure across all sites, particularly after system upgrades or changes. Ensure compliance with regulatory guidelines and procedures to uphold the validated state.

7. Conduct periodic reviews of application systems and IT infrastructure: Regularly review application systems and IT infrastructure to maintain their validated state in accordance with established procedures. This includes performing periodic assessments to ensure continued compliance with regulatory requirements.

8. Manage internal, customer, and regulatory audits: Take ownership of managing internal, customer, and regulatory audits related to IT computer system validation. Ensure compliance with IT CSV procedures and applicable regulations. Provide support in preparing documentation for regulatory submissions and respond to audit findings as needed.

By fulfilling these accountabilities, you will contribute to maintaining compliance with regulatory requirements, ensuring the accuracy and completeness of validation deliverables, supporting the IT team in their professional development, and managing audits and regulatory submissions effectively.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

Experience:

The ideal candidate for this role should have a minimum of 8 years to 15 years of experience in the pharmaceutical and IT service industry. The candidate should have a strong background and expertise in the following areas:

1. CSV (Computer System Validation): Extensive experience in computer system validation, including the validation of IT systems used in a regulated environment. The candidate should have a deep understanding of validation principles, methodologies, and best practices.

2. CSA (Computer System Assurance): Demonstrated experience in computer system assurance, ensuring the reliability, security, and compliance of IT systems. This includes implementing measures to protect against cybersecurity threats, ensuring data integrity, and maintaining the confidentiality of sensitive information.

3. Data Integrity: In-depth knowledge and experience in ensuring data integrity within IT systems, including implementing controls and processes to prevent data manipulation, unauthorized access, and data loss. The candidate should be familiar with regulatory requirements and guidelines related to data integrity, such as ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles.

4. ERES (Electronic Records and Electronic Signatures) Implementation: Proficiency in implementing electronic records and electronic signatures within IT systems, in compliance with regulatory requirements such as 21 CFR Part 11. The candidate should be well-versed in the technical and regulatory aspects of ERES implementation and should have experience in managing ERES projects.

5. IT Application Lifecycle (DevOps): Experience in managing the IT application lifecycle, including requirements gathering, system design, development, testing, deployment, and maintenance. Familiarity with DevOps methodologies and practices, ensuring efficient and collaborative software development and delivery.

6. QMS (Quality Management System): Knowledge and experience in establishing and managing a Quality Management System (QMS) within the IT environment. This includes implementing processes and procedures to ensure compliance, quality assurance, and continuous improvement.

7. Audit: Proven experience in managing and participating in audits, both internal and external, related to IT operations, compliance, and computer system validation. The candidate should be adept at preparing documentation, responding to audit findings, and driving corrective actions.By possessing this extensive experience, the candidate will bring a wealth of knowledge and expertise to effectively handle the responsibilities of the role and navigate the complexities of the pharmaceutical and IT service industry.

Skills and Capabilities

The ideal candidate for this role should possess the following skills and capabilities:

1. Computerized System Validation (CSV): Strong expertise in computerized system validation, including validation strategies, protocols development, execution, and documentation. The candidate should have a thorough understanding of regulatory requirements and industry best practices for CSV.

2. Enterprise and Site-specific Rollout of IT Applications: Experience in managing the rollout and validation of custom (GAMP Category 5) and configured (GAMP Category 4) IT applications across enterprise and site-specific environments. This includes understanding validation requirements, coordinating with stakeholders, and ensuring compliance with regulatory standards.

3. Validation of COTS and Infrastructure Products: Proficiency in validating Commercial Off-The-Shelf (COTS) software (GAMP Category 3) and infrastructure products (GAMP Category 1). The candidate should have a solid understanding of the validation process for these products and ensure their suitability for the intended use in a regulated environment.

4. ERES Implementation and GAP Assessment: Knowledge and experience in implementing Electronic Records and Electronic Signatures (ERES) systems. The candidate should be familiar with ERES regulations, guidelines, and best practices, and be capable of performing GAP assessments to identify compliance gaps and recommend remediation measures.

5. Test Script Writing, Execution, Reporting, and Defect Management: Proficient in developing test scripts, executing test plans, documenting test results, and managing defects throughout the validation process. The candidate should have a meticulous attention to detail and be able to identify and track issues effectively.

6. Software Development Models: Familiarity with software development models such as V model, Agile, and Waterfall. The candidate should understand the principles and processes of these models and be able to adapt them to the validation of IT systems.

7. ITIL and DevOps Basics: Basic knowledge of ITIL (Information Technology Infrastructure Library) and DevOps principles. The candidate should understand IT service management practices and the integration of development and operations for efficient software delivery and deployment.

8. IT Quality Management: Understanding of IT quality management principles, including change control, CAPA (Corrective and Preventive Actions), deviation management, audit management, and root cause analysis (RCA). The candidate should have experience in implementing and maintaining these processes to ensure quality and compliance.

9. IT Security and Administration Basics: Familiarity with IT security principles and best practices, as well as basic knowledge of IT system administration. The candidate should understand the importance of data security, access controls, and system administration procedures.

10. Data Lifecycle Management and Data Integrity: Proficiency in data lifecycle management, including data acquisition, storage, processing, and archival in a regulated environment. The candidate should have knowledge of data integrity principles and practices to ensure the accuracy, completeness, and reliability of regulated records.

11. Project Management Basics: Basic project management skills, including project planning, task management, and coordination. The candidate should be able to effectively manage timelines, resources, and deliverables within the context of IT validation projects.

By possessing these skills and capabilities, the candidate will be well-equipped to handle the challenges of computerized system validation, IT quality management, and data integrity within a regulated environment.

Education

The ideal candidate for this role should have the following educational qualifications:

1. Post Graduate Master's Degree / Diploma in Computer Science and Application or equivalent: The candidate should possess an advanced degree or diploma in computer science and application or a related field. This educational background provides a strong foundation in IT principles, software development, and system implementation.

2. ITIL / Agile Certifications: Possessing certifications in ITIL (Information Technology Infrastructure Library) and Agile methodologies would be advantageous. ITIL certification demonstrates knowledge of IT service management best practices, while Agile certification showcases proficiency in Agile project management and development methodologies.

By having a post-graduate degree or diploma in computer science and application, along with certifications in ITIL and Agile, the candidate demonstrates a deep understanding of IT concepts, project management practices, and industry frameworks. These qualifications enhance the candidate's expertise in IT operations, compliance, and computer system validation, and make them well-equipped to handle the responsibilities of the role effectively.

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 accommodation for qualified individuals with disabilities.