Sr QC Analyst

Job Title: Senior Executive – Quality Assurance

Job Location: Syngene Unit 3 Bangalore

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 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
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

• Responsible for Training Co Ordinator for Quality Assurance and Microbiology department
• Preparation of Job Description for new employees
• Preparation of training curriculum for quality assurance and microbiology departments
• Coordination with the other dept. training coordinators
• Handling of GTR and Attendance updating in LMS/External Training details updation in LMS

Item ID Creation and revision in LMS

• Training room blocking and arrangements with the help of the admin team for internal training and external training.
• Handling of SQDECC meeting and updation of quality metrics data
• To ensure the good documentation practices and ensure the data integrity compliance  
• Involve in Monitoring of process through process step verification. Review of Batch Manufacturing Record to check compliance from stepwise process execution to written instructions
• Reporting any deviations and discrepancies to the superiors and reporting head. Handling of Deviations and its closure at right intervals
• Adherence to procedural systems, cGMP, data integrity & transparency maintained within the organization
• Equipment/Instrument Breakdown, Work Order approvals & tracking usage
• Return and verification approval of unused & excess materials
• Involve in Document Control and Document Issuance
• Involve in Archival of Documents.

Role Accountabilities: Accountable for the above-assigned role

Leadership Capabilities: Must have basic communication skills to interact with other cross functional dept.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. 
   
2. Experience: 5-8 Years
3. Demonstrated Capability: as per the above role
4. Education: M.Pharm / M.Sc / Any Graduate

Experience: 5-8 years

Skills and Capabilities: Microsoft Office, Basic computer skills, MS Office, self-motivated, able to communicate in English

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 accommodation for qualified individuals with disabilities.