Syngene Executive Jobs For MSc Biotech – Apply Online
Title: Senior Executive
Date: 21 Nov 2024
Job Location: Bangalore
Pay Grade:
Year of Experience:
JOB DESCRIPTION
Job Title: IPQC Reviewer
Job Location: Bangalore
Reporting to: Manufacturing
Job Grade: 9
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 the development of procedures, practices, and systems that ensure safe operations and compliance with the 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.
- Ensuring all assigned mandatory training 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.
Key Responsibilities:
- Handling shift and ensuring release of Inprocess/Finished product samples within TAT and by adhering to compliance norms.
- Review of analytical documents related to Inprocess/Finished products/Stability/Method validations.
- Supporting computer system validation activities in the lab.
- Guidance to the analysts on good laboratory and analytical procedures.
Core Purpose of the Role:
- To handle Inprocess analysis and raw materials management as reviewer/shift in charge.
- To support IPQC functions while reporting to manufacturing.
Role Accountabilities:
- To handle the Inprocess and RM team as shift in charge.
- Review of analytical documents related to Inprocess and raw materials.
- 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 of laboratory incidents, OOS, OOT, and deviations.
- 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 the status of audit-related CAPA progress/closure for Quality Governance Forum.
Syngene Values
All employees will consistently demonstrate alignment with our core values:
- Excellence
- Integrity
- Professionalism
Specific Requirements for this Role:
- Experience: 3 – 6 years
- Demonstrated Capability: Shift in charge/reviewer
- Education: M.Sc. Biotech/M.Sc. Chemistry
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