Lead- Internal Quality Audits

2 months ago

Bengaluru, India Syngene Full time

JOB DESCRIPTION

Job Title:

Job Location:

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:

Person must have experience in conducting Quality audits and Compliance Person must have thorough knowledge on various GMP regulatory guidelines and industry trends Awareness of the relevant regulatory requirements and standards that govern IT and CSV audits (e.g., FDA, EMA, GxP, ISO standards). Ability to review and assess documentation such as policies, procedures, work instructions, validation protocols (IQ/OQ/PQ), user requirements, and technical specifications of electronic systems Writing comprehensive audit reports that effectively communicate findings, risks, and recommendations. Knowledge of key cybersecurity principles, such as encryption, firewalls, intrusion detection systems, and security patch management, which impact system security and compliance. Ability to assess IT-related risks and evaluate control measures to mitigate those risks. Understanding of data privacy laws and regulations (e.g., GDPR, CCPA) and their implications for IT systems. Understanding of Good Automated Manufacturing Practice guidelines (GAMP 5), which offer best practices for computer system validation. Familiarity with international guidelines for good manufacturing practices (GMP) and pharmaceutical quality systems as per ICH Q7/Q10. Knowledge of electronic records and electronic signatures regulation, which outlines how to ensure that computerized systems are trustworthy and reliable as per the FDA 21 CFR Part 11. Understanding the principles of a risk-based approach, where the complexity and criticality of the system drive the level of validation effort. Experience in auditing third-party software suppliers and vendors, ensuring they adhere to validation requirements and maintain system integrity. Ability to evaluate change management processes to ensure that any updates to validated systems are controlled and documented. Familiarity with healthcare and laboratory information management systems (LIMS), enterprise resource planning (ERP) systems, and manufacturing execution systems (MES) relevant to Healthcare & Life Sciences IT Systems Experience in applying risk assessments (e.g., Failure Mode and Effects Analysis, FMEA) to determine the validation scope in CSV

Role Accountabilities

Leadership Capabilities:

Proven ability to lead and motivate teams Excellent written and verbal communication skills Strong team player / works well in multi-discipline teams Good interpersonal skills, reads the needs and motivations of others in order to deliver high standards  Builds strong plans to provide clarity for others, and utilizes time management tools and capabilities Analytical strengths and high trouble shooting abilitiy

Syngene Values

All employees will consistently demonstrate alignment with our core values

 Excellence  Integrity  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

Experience Demonstrated Capability Education

Skills and Capabilities

For Leading self, leading with others, and leading a team: Ability to understand the business, and role of different enabling functions is important. Excellent interpersonal skills and demonstrated leadership abilities from the basic qualifications for this role.

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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