Auditor

JOB DESCRIPTION

Job Title: Bioanalytical QA Auditor

Job Location: Semicon park, Bangalore

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 ensure that the studies are conducted as per the protocol, SOP, applicable principles of GLP and GCP guidelines

Role Accountabilities:

Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance’s as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit. Responsible to perform audits and review of processes, raw data and documents including SOPs of bioanalytical method development, method validation, study sample analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house bioanalytical SOPs. Responsible to perform audits and review of processes, raw data and documents including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house pharmacokinetic/ statistical SOPs. Responsible to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols. Responsible to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program. Responsible to prepare and issue audit reports and follow-up the implementation of CAPA to ensure closeout of the audits observations. whenever required assist manager/HOD to collate quality systems data for trend analysis of QA metrics. Responsible to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part) reports as per the scheduled time lines. Responsible to assist or conduct onsite or desktop audit of vendors as per the vendor assessment/reassessment schedule. Responsible to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs, Applicable principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements. Responsible to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function. Responsible to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC. Responsible to update and consult manager/HOD when delivering the current job responsibility and escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance. Responsible to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management. Responsible to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.

Syngene Values

All employees will consistently demonstrate alignment with our core values

 Excellence  Integrity  Professionalism

Specific requirements for this role

Experience – 8 to 12 years

Skills and Capabilities

 Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance's as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.

Education -M Pharm / M.Sc. Life Science

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.

JOB DESCRIPTION

Job Title: Bioanalytical QA Auditor

Job Location: Semicon park, Bangalore

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 ensure that the studies are conducted as per the protocol, SOP, applicable principles of GLP and GCP guidelines

Role Accountabilities:

Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance’s as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit. Responsible to perform audits and review of processes, raw data and documents including SOPs of bioanalytical method development, method validation, study sample analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house bioanalytical SOPs. Responsible to perform audits and review of processes, raw data and documents including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house pharmacokinetic/ statistical SOPs. Responsible to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols. Responsible to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program. Responsible to prepare and issue audit reports and follow-up the implementation of CAPA to ensure closeout of the audits observations. whenever required assist manager/HOD to collate quality systems data for trend analysis of QA metrics. Responsible to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part) reports as per the scheduled time lines. Responsible to assist or conduct onsite or desktop audit of vendors as per the vendor assessment/reassessment schedule. Responsible to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs, Applicable principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements. Responsible to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function. Responsible to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC. Responsible to update and consult manager/HOD when delivering the current job responsibility and escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance. Responsible to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management. Responsible to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.

Syngene Values

All employees will consistently demonstrate alignment with our core values

 Excellence  Integrity  Professionalism

Specific requirements for this role

Experience – 8 to 12 years

Skills and Capabilities

 Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance's as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.

Education -M Pharm / M.Sc. Life Science

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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