Title: ASSOCIATE EXECUTIVE
JOB DESCRIPTION
Job Title: Associate Executive
Job Location: Biocon Park, Bangalore
Reporting to: Manager
Job Grade: 10-II
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 :
- Responsible to maintain the Stability chambers of different conditions as per ICH requirements.
- Responsible for the review manage and review of the Chamber Qualifications, calibration, Preventive maintenance, and chamber mapping activities.
- Responsible for preparation of Chamber Alaram and excursion reports.
- Responsible for daily review of ICDAS temperature and humidity records.
- Should be able to the identify and analyze the chamber breakdowns to avoid temperature excursions.
- Responsible for managing Chamber breakdown and excursions and coordinating with QC, EAM and vendors, based on the requirements.
- Responsible for maintaining Chamber schedules for Calibrations, Preventive maintenance, and mapping activities.
- Responsible to comply with Syngene Quality procedures, Safety procedures and Data integrity procedures.
- Should participate in Audits for chamber related discussions.
Role Accountabilities
- Chamber Management
- Quality compliance
- Regulatory compliance
- Audit participation
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Accountabilities as a Syngene Leader (only for Leadership Hires)
- 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
- Experience
- Demonstrated Capability
- Education
Experience
- 3 - 5 years in chamber management and trouble shooting
Skills and Capabilities
- cGMP experience
- awareness on Data integrity policies and requirements
- Good evaluation skills
- Good English communication skills
- Stake holders management skills
- Chambers management
Education: Diploma in instrumentation or any other suitable education