Job Description

JOB DESCRIPTIONJob Title: Clinical QA AuditorJob Location: BangaloreAbout Syngene : Syngene ( ) 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 spiritMandatory 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 :

• To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc.,
• To perform study specific retrospective audits of informed consent document, study files like TMF, case report forms, raw data forms, draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc.,
• To perform database audits in EDC application for applicable studies.
• To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations.
• To initiate change control and follow-up for the same for timely closure in consultation with Manager/ Department Head.
• To review change control, deviation and other QMS elements taken by operations team and follow-up for its timely closure.
• To review draft documents like Protocol, ICD, CRF etc., before its finalization.
• To assist for system audit as co-auditor and or providing input to Compliance QA team, if required.
• To perform vendor audit as lead/ co-auditor as per vendor audit forecast plan, if required.
• To review qualification and validation documents, if required by Manager/ Department Head.
• To assist and or participate whenever required as per Department Head discretion during system audit, internal and external audits and inspection as part of audit/ inspection readiness.
• To assist in preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection.
• To ensure QA records generated are archived on periodic basis.
• To assist Manager/ Department Head whenever required to collate quality systems data for trending the Quality metrics.
• To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles.

Other Responsibilities: * To perform or assist any other relevant job with relevant training as and when required by Department Head or Management.Role Accountabilities * To perform In-process audit(s) at various stages, based on the study design & risk

• To perform retrospective audit(s) of clinical study documents against the study protocol, in-house SOP(s) and applicable regulatory guidelines & guidance(s)

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

• Experience: 6-9 years
• Demonstrated Capability: Auditing skills, Understanding of regulations & Attention to detail
• Education: M.Sc or M. Pharm

Equal Opportunity EmployerIt 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.

Syngene International