Title:  QA Auditor: Biometrics

JOB DESCRIPTION

Job Title: Quality Assurance Auditor: Biometrics (Pharmacometrics & statistics)

Job Location: Bangalore

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: Quality Assurance Auditor: Biometrics (Pharmacometrics & statistics)

   Role Accountabilities

• To perform the role as a Biometrics QA and be responsible for QA review or audits of the Pharmacometrics (pharmacokinetics or pharmacodynamics) and statistical process, procedures, programs and data analysis activities for BA/BE studies and phase I-IV clinical trials and assure compliance with ICH-GCP (R2), study protocol and other applicable regulatory requirements and guidance.
• To perform the Quality Assurance review of draft study protocols and Investigator Brochures (IB) regarding the pharmacokinetic/ pharmacodynamics analysis and statistical analysis plan for BE/BA studies and phase I (including SAD/MAD studies), II- IV clinical trials to assure compliance with ICH-GCP (R2) and other applicable regulatory requirements and guidance.
• Quality Management System (QMS): Responsible for review of QMS elements of Biometrics and other support departments of Syngene Clinical Development.
• Audit Management: Plan (including preparation of relevant audit related documents, review of documents) and perform relevant audits: study-based audits, quality system audits, process audits. Prepare audit reports, review corrective and preventive action plan generated and follow-up on the closure of the same. Alternatively, follow-up audits can be done. 
• To perform the QA review of statistical (SAS® analysis) programs & perform QA audit of the statistical results and SAS® datasets of BE/BA studies and phase I-IV clinical trials and assure compliance with ICH-GCP (R2), study protocol, SOPs and other applicable regulatory requirements.
• To perform the QA review on final draft Clinical study report and its appendices related to biometrics and CDISC requirements such as clinical datasets (STDM) and analysis datasets(ADaM) assure that applicable regulatory requirements are fulfilled.
• Responsible for review of user required specification (URS)/user acceptance testing (UAT) of internal computerized systems and third-party service providers to assure software validation/assurance and 21CFR part 11 compliance requirements.
• Ensure quality assurance (QA) on all process and technical activities related to WinNonlin / SAS® application derived dataset, table, listing, and figure programming in accordance with best quality standards.
• Standard Operating Procedures’ (SOPs’): Preparation and revision of SOPs’ relevant to QA area; review of SOPs related to biometrics and SAS programming; Any other responsibilities as indicated in relevant SOPs.
• 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 Biometrics 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.
• Effectively plan & collaborate co-audits with compliance QA team to conduct scheduled & unscheduled QA system audits of biometrics and clinical SAS programming operations to ensure that Pharmacometrics (pharmacokinetics or pharmacodynamics) and statistical process, procedures, programs and data analysis 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.
•  

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

• Experience: 5 to 7 years in generation or review of pharmacokinetics or pharmacodynamics and statistical data in clinical research field
• Demonstrated Capability: Independently perform and review of PK/PD modelling and statistical analysis for Phase I, II trials and BABE studies (Skills: R | Phoenix WinNonlin | SAS 9.4)

Review of Statistical Analysis Plan for First in Human (SAD), Phase II – IV trials and review trial protocols, SAS datasets, TLF’s and Clinical Study Reports

Review and ensure compliance of Pharmacometrics & Statistical processes and programs to regulatory requirements.

 Education: M. Pharm, PharmD, M.Sc. (Biostatistics)

Skills and Capabilities: 1. Knowledge on PK/PD modelling in BABE studies and different Phases of clinical trail

2.Proficiency in statistical programming using SAS 9.4 (Base SAS Certified),  R Studio and Phoenix WinNonlin

3.Knowledge on 21 CFR part 11

4.Knowledge on Good clinical practice

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: Quality Assurance Auditor: Biometrics (Pharmacometrics & statistics)

Job Location: Bangalore

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: Quality Assurance Auditor: Biometrics (Pharmacometrics & statistics)

   Role Accountabilities

• To perform the role as a Biometrics QA and be responsible for QA review or audits of the Pharmacometrics (pharmacokinetics or pharmacodynamics) and statistical process, procedures, programs and data analysis activities for BA/BE studies and phase I-IV clinical trials and assure compliance with ICH-GCP (R2), study protocol and other applicable regulatory requirements and guidance.
• To perform the Quality Assurance review of draft study protocols and Investigator Brochures (IB) regarding the pharmacokinetic/ pharmacodynamics analysis and statistical analysis plan for BE/BA studies and phase I (including SAD/MAD studies), II- IV clinical trials to assure compliance with ICH-GCP (R2) and other applicable regulatory requirements and guidance.
• Quality Management System (QMS): Responsible for review of QMS elements of Biometrics and other support departments of Syngene Clinical Development.
• Audit Management: Plan (including preparation of relevant audit related documents, review of documents) and perform relevant audits: study-based audits, quality system audits, process audits. Prepare audit reports, review corrective and preventive action plan generated and follow-up on the closure of the same. Alternatively, follow-up audits can be done. 
• To perform the QA review of statistical (SAS® analysis) programs & perform QA audit of the statistical results and SAS® datasets of BE/BA studies and phase I-IV clinical trials and assure compliance with ICH-GCP (R2), study protocol, SOPs and other applicable regulatory requirements.
• To perform the QA review on final draft Clinical study report and its appendices related to biometrics and CDISC requirements such as clinical datasets (STDM) and analysis datasets(ADaM) assure that applicable regulatory requirements are fulfilled.
• Responsible for review of user required specification (URS)/user acceptance testing (UAT) of internal computerized systems and third-party service providers to assure software validation/assurance and 21CFR part 11 compliance requirements.
• Ensure quality assurance (QA) on all process and technical activities related to WinNonlin / SAS® application derived dataset, table, listing, and figure programming in accordance with best quality standards.
• Standard Operating Procedures’ (SOPs’): Preparation and revision of SOPs’ relevant to QA area; review of SOPs related to biometrics and SAS programming; Any other responsibilities as indicated in relevant SOPs.
• 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 Biometrics 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.
• Effectively plan & collaborate co-audits with compliance QA team to conduct scheduled & unscheduled QA system audits of biometrics and clinical SAS programming operations to ensure that Pharmacometrics (pharmacokinetics or pharmacodynamics) and statistical process, procedures, programs and data analysis 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.
•  

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

• Experience: 5 to 7 years in generation or review of pharmacokinetics or pharmacodynamics and statistical data in clinical research field
• Demonstrated Capability: Independently perform and review of PK/PD modelling and statistical analysis for Phase I, II trials and BABE studies (Skills: R | Phoenix WinNonlin | SAS 9.4)

Review of Statistical Analysis Plan for First in Human (SAD), Phase II – IV trials and review trial protocols, SAS datasets, TLF’s and Clinical Study Reports

Review and ensure compliance of Pharmacometrics & Statistical processes and programs to regulatory requirements.

 Education: M. Pharm, PharmD, M.Sc. (Biostatistics)

Skills and Capabilities: 1. Knowledge on PK/PD modelling in BABE studies and different Phases of clinical trail

2.Proficiency in statistical programming using SAS 9.4 (Base SAS Certified),  R Studio and Phoenix WinNonlin

3.Knowledge on 21 CFR part 11

4.Knowledge on Good clinical practice

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.