Compliance QA Auditor

Job Title: Assistant Manager -Compliance 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 (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 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 Syngene's 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

1. Experience: 8-10 Years
2. Demonstrated Capability: as per the above role
3. Education: M.Pharm or Master’s in Science

Skills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in English

Education M.Pharm or Master’s 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.