Title:  Reviewer/Shift In-Charge

JOB DESCRIPTION

Job Title: Reviewer/Shift In-Charge

Job Location: Bangalore, Biocon Park

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

Core Purpose of the Role:

• To handle the Inprocess and Finished products team as shift in charge.
• Review of Analytical documents related to Inprocess/Finished products/Stability/Method validations.
• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• To support Computer system validation activities in the laboratory.
• Handling Internal audits, Client audits and Regulatory Audits pertaining to Biologics Operations Unit.
• Coordinate for Internal Audits in consultation with Internal Quality Audit Team as per the schedule.
• Coordination with cross functional departments on the status/ progress of Audit related CAPA on a weekly basis.
• Tracking follow- up and closure of CAPAs triggered through external audits, internal audits and self-inspections. Provide data and updates on the same to Internal Quality Audit team on a monthly basis.
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• Provide data on status of audit related CAPA progress/closure for Quality Governance Forum.
• Assessment of FDA 483 observation reports and regulatory guidelines against current systems in Syngene.

Role Accountabilities:

• Handling shift and ensuring release of Inprcoess/Finished product samples within TAT and by adhering to compliance norms.
• Review of Analytical documents related to Inprocess/Finished products/Raw materials and stability/validations.
• Supporting Computer system validation activities in the lab.
• Guidance to the analysts on good laboratory and analytical procedures.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role:

• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Ability to provide solutions for complex problems.

Demonstrated Capability-

1. Knowledge on Biologics Manufacturing and testing compliance requirements.
2. Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
3. Tactful communication.

Education

M. Sc. (Biochemistry/Chemistry)

Experience

8-10 years

Skills and Capabilities:

• Aggressive but assertive on task completion.
• Personal integrity and good attitude.

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.