Project QMS Reviewer
Project QMS Reviewer
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Job Description
JOB DESCRIPTION
Job Title: Project QMS Reviewer
Job Location: Syngene International Limited Bengaluru
About Syngene : Syngene () 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 companys 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 integrityhealth 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:
This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing.
Role Accountabilities:
Follow GMP GDP and GLP procedures as applicable while performing the assigned task. Create/ revise/ review of procedures (like SOP protocols calibration schedule and other related documents as applicable.). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs PDRs SOPs EOPs and the product details batch no. quantity label purchase order RM issue slip CoA weights packing and dispatch record packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation LIR OOS OOT Change control & Complaints). Handling of returned products and product recall.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience
- Demonstrated Capability
- Education
Experience
6 - 9 years Handled Project related QMS activities (Change control Deviations CAPA OOS LIRs)
Must have handled clients
Expertise in review of Master Batch Record Batch Record and Analytical Documents
Knowledge on Good Documentation and laboratory practices
Good coordination among CFTs
Skills and Capabilities
Expertise in handling QMS Activities
Good knowledge about project related activities
Client handling experience
Master Batch Record Batch Record and Analytical Document Review skills
Specification and Method of analysis review
Good communication skills
Batch Release
Education
MSc. Chemistry
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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Employment Type
Contract
