Title:  Drug substance QA

JOB DESCRIPTION

Job Title: Assistant. Manager

Job Location: Bangalore Syngene unit 3

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:

• Line Clearance process overview, Product change over.
• Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status.
• Monitoring of process through process step verification.
• Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions.
• Equipment / utility Qualifications, Calibrations, PM verification.
• Utility / Computer system validation
• Process validation and cleaning validation.
• Target Monitoring for batch related process activities.
• cGMP compliance and verification overview of BMP facility & Utilities.
• SOP preparation and review.
• Training
• GEMBA principles
• Quality management system, investigation.

Role Accountabilities

• Anytime audit readiness
• Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status for manufacturing.
• Utility & Manufacturing area and document compliance.
• Equipment / utility Qualifications, Calibrations, PM verification.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience 9 – 12 years
2. Demonstrated Capability – Process QA, Manufacturing compliance.
3. Education MSc

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.