QA Auditor - Bioanalytical

JOB DESCRIPTION

Job Title: Auditor –Bioanalytical QA

Job Location: Bangalore

Job Level: Foundational

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 (EHSS) 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 (EHSS) 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 project specific bioanalytical, pharmacokinetic (PK), statistical data audits as per the QA SOPs and audit programmes to ensure compliance with inhouse bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidances as per the scheduled timelines.

• To perform audits and review of processes, raw data and documents including SOPs/STP of bioanalytical method development, method validation, to ensure compliance as per the applicable regulatory guidance and inhouse bioanalytical SOPs.

• To review method validation/addendum, bioanalytical, clinical /statistical study report.

• To review bioanalytical and pharmacokinetic/ statistical sections of the study protocols.

• To prepare/review and issue audit reports and follow-up the implementation of CAPA to ensure close out of the audit observations. Whenever required to collate quality systems data for trend analysis of QA metrics.

• To prepare/review/approve QA statements for bioanalytical validation reports.

•  To prepare/review QA statements for clinical study report reports.

• To assist or conduct periodic internal quality system/ facility audits or process audits in different processes, instrumentation and software applications and its documentation in bioanalytical and pharmacokinetic/ statistical departments/other departments.

• To assist or conduct whenever required audits of quality system or facility, as part of regulatory      inspection/sponsor audit readiness program.

• To initiate change control/deviation/CAPA within QA department if needed.

• To review change control/deviation/CAPA raised by operational unit.

• Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and     advice on resolving issues.

• Review of qualification and validation documents.

• Review relevant documents (qualification and validation documents) pertaining to the computerized system.

• To assist or conduct onsite or desktop audit of vendors as per the vendor   assessment/reassessment schedule.

• Participate in sponsor audits and regulatory inspections by preparing for the audit with the relevant department for preparation. Interact with auditors/inspectors – accompany and answer queries during the audit/inspection. Prepare and review relevant corrective and preventive action plan and follow-up on the implementation of the same.

• To perform QA review SOPs for bioanalytical, pharmacokinetic/ statistical department, to ensure compliance with internal SOPs, principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements. 

• To author/review SOPs for GCP quality assurance function SOPs and conduct training of     relevant SOPs to staff of operational unit.

• To periodically update and maintain own training records/binder and train the trainee auditors.

• Ensure QA records generated are archived on a periodic basis.

• To escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Skills and Capabilities Auditing of BA/BE documents generated form clinical development, Knowledge on ICH GCP guidelines.  

Education- M.Sc. (science, biotechnology) B. Pharmacy / M. Pharmacy   

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.