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.
Core Purpose of the Role:
As the IT Subject Matter Expert (SME) for MES (Manufacturing Execution System) and Technical Support Systems in the pharmaceutical industry, you will be responsible for providing expertise and support for these critical systems. Your role will involve ensuring the efficient operation of the MES system and providing technical support to end-users. You will collaborate with cross-functional teams to optimize system performance, implement enhancements, and ensure compliance with industry regulations.
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Serve as the primary point of contact and subject matter expert for the MES system and technical support systems.
Provide technical support and troubleshooting for end-users, ensuring timely resolution of system-related issues.
Responsible for support of MES integration - L2 integration with multiple systems parts of MES Implementation (Weighing, Dispensing, SAP, QMS & DMS integration)
Participate in system validation activities, including documentation, testing, and change management processes, to ensure compliance with regulatory standards.
Develop and deliver training programs for end-users to maximize their proficiency in utilizing the MES system and technical support systems.
Assist in the evaluation and selection of new systems or upgrades, ensuring compatibility and integration with existing IT infrastructure.
Collaborate with cross-functional teams to define and implement standard operating procedures and best practices for system usage.
Develop and implement computer system validation strategies, policies, and procedures in alignment with regulatory guidelines, such as FDA 21 CFR Part 11 and EU Annex 11.
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Technical and Leadership skills:
In-depth knowledge and expertise in MES systems, such as Rockwell PharmaSuite, Werum PAS-X, Syncade, or similar platforms, and technical support systems commonly used in the pharmaceutical industry.
Proficiency in troubleshooting system issues, analyzing system performance, and implementing system enhancements.
Excellent communication skills to effectively collaborate with cross-functional teams, end-users, and vendors.
In-depth knowledge of computer system validation principles, methodologies, and regulatory guidelines, such as GAMP 5 and FDA regulations.
Strong analytical and problem-solving skills to assess validation risks and develop effective mitigation strategies.
Excellent communication and interpersonal skills to collaborate with stakeholders at all levels, including IT professionals, system owners, and regulatory agencies.
Leadership abilities to guide and influence project teams and stakeholders in the validation process.
Detail-oriented mindset with the ability to review and approve validation documentation accurately.
Knowledge on data backup, restore for GxP instruments.
Must have experience handling Internal Audit and external regulatory Audits – FDA Audit coordinates with team support MES-related information and compliance towards 21 CFR part 11.
Qualification & Experience:
Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field.
Extensive experience working with MES systems and technical support systems in the pharmaceutical industry.
Solid understanding of manufacturing processes, quality systems, and regulatory compliance requirements in a pharmaceutical manufacturing environment.
Proven experience in providing technical support and troubleshooting for MES systems and technical support systems.
Strong knowledge of system validation processes, documentation, and change management in a regulated environment.
Familiarity with quality management systems (QMS) and good documentation practices (GDP).
Experience with regulatory inspections and audits related to computer system validation.
Strong written and verbal communication skills.
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.
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