QA Auditor- CDM

JOB DESCRIPTION

Job Title: Clinical Data Management QA Auditor

Job Location: Semicon Park

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:

• To perform the role as a clinical data management (CDM) - QA auditor and be responsible for QA review or audits for clinical data management activities for BA/BE studies, phase I, II, III and IV studies
• To verify and assure compliance with ICH-GCP (E6 R3), study protocol, study data management plan (DMP)and other applicable regulatory requirements.
• To perform QA review and assist in development of standard operating procedures (SOPs) for clinical data management activities for BA/BE studies, phase I, II, III and IV studies.
• To perform QA review of study set up requirements such as CRF review and data base annotations in EDC platforms to assure study protocol requirements are fulfilled for phase I, II, III and IV studies.
• To perform QA review of study specific requirements, regarding CDISC and study data standards.
• To collate data for quality KPI metrics and report the trends for CDM related function.
• When indicated by Manager, perform vendor/sub-contractor qualification/surveillance audits (onsite/remote) and provide updates on audit outcome/closeout status and follow-up as indicated.
• Collaborate with CDM operations in lessons learned debrief sessions to identify the need for continuous improvement and for potential changes to work practices to create robust GxP quality systems.
• Escalate and consult with CDM operations regarding perceived GCP related vendor performance issues and when indicated consult them to develop a corrective and preventative (if applicable) action plan.
• Effectively plan & collaborate co-audits with compliance QA team to conduct scheduled & unscheduled QA system audits to ensure that clinical data management activities delivered by Syngene clinical development are of the Highest standards and are in compliance with the requirements of SOPs, Study protocols, relevant regulations & guideline.

Follow-up of study/client/sponsor audits:

• Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses (CAPA) as necessary to ensure timelines are met and responses of satisfactory quality are obtained.
• Collaborate with the appropriate CDM Operations team members in follow-up, to the sponsor/client audits to ensure resolution of audit findings with the appropriate CAPA in accordance with GCP and other applicable regulatory requirements and relevant best GxP practices.

Maintain quality records / systems:

• Maintain required Syngene QA tools and ensure Syngene QA systems are regularly updated with accurate information for audits and other activities.
• Facilitate clinical trial sponsor audits for clinical data management as assigned in collaboration with compliance QA team.

• Facilitate clinical trial regulatory inspections clinical data management as assigned in collaboration with Sponsor representative.
• Foster a good working relationship with internal and external stake holders to promote compliance within Clinical development operating unit for function conducting clinical data management activities for BE/BA & Phase I studies /patient based clinical trials.
• Working knowledge and expertise of Syngene policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
• Proactively recognize areas for process / procedural improvements, providing input to clinical data management function and taking the initiative, as appropriate to ensure implementation.

Audit performance and reporting:

• Plan, schedule, conduct and report a range of GCP/GxP (CSV, 21CFR part 11) compliance audits in accordance with client requirements and Syngene/Sponsor procedures, independently or with minimal supervision.
• Perform and deliver high quality audits /audit reports within specified timelines / budgets.
• Lead or participate in co-audits / observed audits with client representatives or other QA auditors as and when required
• Travel nationally /internationally for QA audits as required.
• Ensure that the audit observation and findings are formally recorded & reported & that corrective/preventive actions are documented as per the QA SOP/ tools.
• Perform the assigned duties in an efficient & effective manner. This includes liaison with the project manager on all QA issues & provide support to project teams on GCP compliance aspects.
• When required shall author QA SOPs and shall perform QA review of cross functional operation’s SOPs when required or assigned.

• Conduct training of Syngene staff regarding GCP, QA SOPs, the tool of QA & coordinate for proper implementation of respective SOPs.
• Provide support & resources for regulatory inspections & sponsor audits.
• Support GCP- Quality Head in planning/readiness and handling the trial site regulatory inspections/Sponsor audits as required.

Quality and safety

• 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 always.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always 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 always.
• Hold self and your teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time

Role Accountabilities: Accountable for the above-assigned role

Leadership Capabilities: Must have advanced communication skills in English to interact with Cross functional and external stakeholders.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience: 8-10 Years
2. Demonstrated Capability: as per the above role
3. Education: M.Sc. / Any life science Postgraduates

Experience: 8 -10 years

Skills and Capabilities: Advanced computer skills (MS Office, MS excel, PowerPoint) and proficient in EDC platforms, self-motivated.

Education M.Sc. / Any Life sciences Postgraduates

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.