Title:  METHOD VALIDATIONS LEAD

JOB DESCRIPTION

Job Title:  Manager – Quality Control biologics

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
• To manage the Method Validation/Method transfer and Method verification efforts in QC Biologics
• Shall be able to lead the method validation efforts for biologics methods- specifically plate based methods (HCP, HCDNA, Elisa etc.) and cell-based assays
• Shall be well versed with Bioanalytical techniques (iCE, CE, HPLC, GC, etc.) and its validation requirements
• Shall be a second line to HOD of QC Biologics and support QC functions
• Shall be well versed with management skills and people management
• Shall handle the Regulatory audits namely USFDA, EUGMP, Health Canada and others
• To handle the associated Quality management system documents such as investigation of OOS/Deviations/Incidents etc.
• To initiate/close change controls with proper justifications.
• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• Preparation and review of standard operating procedures (SOP).
• 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.

Core Purpose of the Role:

• To handle method validations efforts independently and be a second line for QC HOD

Role Accountabilities:

-Timely delivery of Method validation/Transfer and Verifications

- Delivery in-line with the guideline requirements

- Quality work and commitment

--Client satisfaction and timely delivery

Leadership Capabilities

• Shall act as second line to QC HOD for Biologics vertical
• Shall be a people’s manager
• Shall have managerial skills and management skills
• Shall have exposure to regulatory audits

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Accountabilities as a Syngene Leader

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

1. Experience: At least 15 years

2. Experience

• Exposure to plate based and cell-based method validations/transfer and verification
• Leadership skills

3. Skills and Capabilities

1. Partners with customer
2. Adopts stye against customer need
3. Simplifies the complexity
4. Builds robust plans
5. Demonstrates courage when under pressure
6. Works well across teams and functions
7. Provides regulatory feedback to others.

4. Education:

• M. Sc. Biotechnology

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.