Compliance QA Auditor
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Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Assistant Manager -Compliance QA Auditor
Job Location: Bangalore
About Syngene : Syngene () 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 companys 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 integrityhealth 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 coordinate process excellence projects in Translational & Clinical Research to ensure quality & compliance with GCP systems & practices.
- Complete strategic projects and Kaizen events for GCP Quality domain in alignment with Syngenes strategic deployment plan
- Responsible for performing internal audits assess the systems and practices for improving the GCP Quality System practice independently and in consultation with GCP Quality Head. .
- To ensure that GCP QA Audit Management Corrective and Preventive Action (CAPA) Management Systems are in compliance.
- To conduct audits for the vendors accompanying with other QA auditors during audit of vendors.
- To conduct system audits for - Human Pharmacology Unit (Clinical)
- To handle external clients
- Standard Operating Procedures (SOPs): Preparation and revision of SOPs relevant to their area; review of SOPs from relevant departments; Any other responsibilities as indicated in relevant SOPs.
- Change Control: Take relevant change controls review of change control taken by the departments follow up of the same for closure.
- Record control ensure that all records are written legible. Control and maintain records in the QA department.
- Review relevant documents (qualification and validation documents) pertaining to the Computerized system. Audit relevant computerized system during study audits and system audits.
- Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues.
- Any other job indicated by the Management and / or Manager or Head QA.
Role Accountabilities: Accountable for the above-assigned role
Leadership Capabilities: Must have basic communication skills to interact with dept. training coordinator
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience: 8-10 Years
- Demonstrated Capability: as per the above role
- Education: or Masters in Science
Skills and Capabilities: Microsoft Office Basic computer skills MS Office self-motivated able to communicate in English
Education or Masters in 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
About Company
We are an innovation-led contract research, development and manufacturing organization offering end-to-end solutions to fulfil R&D and manufacturing requirements of our clients
