QA Auditor -Bioanalytical

Job Title: Bioanalytical QA Auditor

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 (EEHS) 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 Management System (QMS): Responsible for the QMS of departments related to Bioanalytical Research Laboratory, Data Management and Biostatistics and other support departments of Syngene Clinical Development.
• Standard Operating Procedures (SOPs): Preparation and revision of SOPs, review of SOPs from relevant departments, any other responsibilities as indicated in relevant SOPs.
• Change Control: Initiate relevant change controls, review of change control taken by the departments, follow up of the same for closure.
• Record control -Control and maintain records in the QA department.
• Qualification and validation: Review of qualification and validation documents.
• Audit Management: Plan (including preparation of relevant audit related documents, review of documents) and perform relevant audits: study-based audits (including site audits), quality system audits, process audits. Prepare audit reports, review audit reports generated by peers, review corrective and preventive action plan generated and follow-up on the closure of the same. Alternatively, follow-up audits can be done.
• Authorized to conduct vendor audits.
• Review of relevant documents such as protocol, testing procedures, study plan, clinical study report; and so on.
• Share best practices and ideas with fellow QA personnel.

Role Accountabilities

• To review protocol / SOPs related to bioequivalence
• To conduct in process during method validation and study sample analysis
• To perform retrospective audit (during review raw data chromatogram)
• To review method validation and bioanalytical report
• To review pharmacokinetic and statistics analysis data
• To review clinical study report

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1.Experience-12 to 14 years worked as bioanalytical QA

2.Skills and Capabilities- Knowledge on QA/GCP/GLP/Bioanalytical guidance/21 CFR guidance

Knowledge about pharmacokinetic and pharmacodynamics

3.Education-M. Pharm or M.sc

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.