Title:  Validation Lead

JOB DESCRIPTION

Job Title: CQA-Validation Lead

Job Location: Syngene International Limited, Bengaluru

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 purpose of the role is to handle the Qualification and Validations Projects across the Manufacturing and testing facilities as an SME and quality compliance in line with evolving regulatory expectations and client requirements. Corporate governance for common engineering systems across the organization.

Role Accountabilities

• Lead and manage the CQA Validation team by mentoring, motivating, and guiding team members towards achieving company goals, maintaining safety practices, and ensuring high performance and success.
• Ensure quality compliance of all the Qualification and Validation activities across Syngene GMP verticals (Biologics, API, and Formulations).
• Drive excellence in validation processes by identifying opportunities for improvement and implementing lean methodologies.
• Should possess experience in leading Equipment Qualifications and Computer System Validations. and should have execution experience in greenfield and brownfield projects.
• Identify and coach team members for development, monitor improvement activities, and support their professional growth.
• Identify training needs from audits and facilitate team development through group discussions, seminars, and workshops. Conduct training on new or revised corporate validation procedures for effective implementation.
•  Provide regular updates on Qualification and Validation projects, offering key insights to Quality Management forums.
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• Participate in Qualification project planning, Schedule preparation in coordination with the project Management team, and ensure compliance.
• Ensure 21 CFR Part 11, Annex 11, and DI compliance through internal policies and procedures at Manufacturing facilities/systems.
• Identify and implement a simplification process for qualification and engineering systems.
• Draft policies and procedures for Corporate quality/Validation function.
• Evaluate Engineering service providers' competencies suitable for qualification/validation projects and audit compliance.
• Handle regulatory and client audits, support internal audits and ensure compliance with internal KPIs.
• Liaise with department and BU heads on the adequacy of proposed actions in managing risk areas highlighted in internal & external audits.
• Ensure timely closure of QMS actions initiated as part of audit outcome and Quality committee review action points.
• Monitor qualification projects/remediation progress with the validation team lead and provide timely solutions to ensure quality commitments.
• Provide support in assessing Change Control requests and reviewing the risk assessment related to validation activities.
• Responsible for the Quality oversight of process validation and method validation activities and work in enhancing and harmonizing validation requirements across GMP verticals.
• Coordinate with functional and OU leads on critical project forecasts and proactive planning for resource mapping.
• Support investigations for potential compliance issues in Engineering systems.
• Understand the complexities of procedures and regulations for Pharmaceutical/Healthcare industries to ensure continual improvement of systems.
• Work with site quality and manufacturing team to support in resolving compliance issues.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role:

1. Experience
2. Demonstrated Capability
3. Education

Experience:

• About 15 + years of work experience in the pharmaceutical or biotech industry or CDMO sector.
• Equipment and Utility qualification, CSV experience.Work exposure to the process and cleaning validation is preferred.

Skills and Capabilities

• Technical knowledge in API, Biologics, and Formulations.
•  Should have minimum 10 years of work experience in Pharmaceutical Validation systems (Facilities, Utilities, Equipment, and Computerized Systems).
• Life Science QMS procedures.
• Should be knowledgeable on validation guidelines per different regulatory requirements and Industrial bodies, e.g., ICHQ2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, and PICS.
•  Interpersonal skills to establish collaboration with cross-functional teams
• Establish good Interpersonal skills with cross-functional teams.
• Capable of thinking scientifically to address complex problems and develop solutions.
• Work as a team and have a collaborative mindset.
• Good communication skills

Education

• M.Sc / M. Pharm/ B. Pharm/ M.Tech/B.Tech .

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.