IPQC Analyst

JOB DESCRIPTION

Job Title: IPQC Analyst

Job Location: Bangalore

Reporting to: Manufacturing

Job Grade: Senior Executive

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

Key Responsibilities:

• Ensuring release of Inprcoess and raw materials analysis on time and in shifts
• Supporting Computer system validation activities in the lab.
• Supporting calibration of instruments

Core Purpose of the Role :

To handle Inprocess analysis and raw materials analysis in shifts

To support IPQC functions while reporting to manufacturing

Role Accountabilities

• To handle the Inprocess and raw materials analysis.
• To perform calibrations
• To handle instrument such as HPLC, SoloVPE, UV, Capillary Electrophoresis, iCE etc.
• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• To support Computer system validation activities in the laboratory.
• Handling of Laboratory incidents, OOS, OOT and deviations
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• To ensure the completion of trainings allotted in time and support the team lead for achieving the deliverables.
• Adhere to the SOP/IOP and perform the analytical activities.
• Adhere to the good laboratory practice and compliance.
• Ensure error free analysis and documentation.
• Co-Ordinate with external vendors for ensuring timely calibration and PM activities.

Leadership Capabilities

• Continuous Learning and Improvement
• Accountability and Integrity
• Collaboration within the team
• Aggressive but assertive on task completion.
• Personal integrity and good attitude.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1. Experience: 3-6 years
2. Demonstrated Capability: Shift operations
3. Education: M. Sc. Biotech/M.Sc. Chemistry

Skills and Capabilities:

Entry level analytical skills

Shift management

Handling of QMS

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.