QA Auditor- GCP Compliance

JOB DESCRIPTION

Job Title: Associate Manager: Compliance QA Auditor

Job Location: Bangalore

Job level : 7-I

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 :

Role Accountabilities:

• To coordinate process excellence projects in Translational & Clinical Research, to ensure quality & compliance with GCP systems & practices.
• To lead the design and implementation of improvement initiatives or events for complex processes that have a large cross-functional impact to eliminate waste, reduce cycle time and improve business performance as a part of continuous improvement.
• To complete strategic projects and Kaizen events for GCP Quality domain, in alignment with Syngene's strategic deployment plan.
• To perform and assess GCP quality systems for Gaps and identify process excellence projects for implementation.
• To perform data trending & data analysis and present metrics
• To 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 manage and perform Internal Audits for GCP Quality Systems.
• To ensure that GCP QA Audit Management, Corrective and Preventive Action (CAPA) Management Systems are in compliance.
• To adherence to strategic direction set by GCP Head Quality when establishing near-term goals.
• To conduct audits for the vendors, accompanying with other QA auditors during audit of vendors.
• To conduct system audits for - Human Pharmacology Unit
• To handle external clients
• To perform or assist any other relevant job with relevant training as and when required by Department Head or Management

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience:

10-15 years

2. Demonstrated Capability:

Expert in Data Analysis, Data Trending and familiar in PowerBI

Knowledge in GCP/ GLP/ GMP with expertise in Data Metrics

Green Belt in SixSigma

Auditing skills, Understanding of regulations & Attention to detail

3. 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.