Title:  Sr. Analyst - QC

                                                                                  JOB DESCRIPTION

Job Title: Sr. Analyst - QC

Job Location: Bengaluru

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
• 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 :

Analysis of raw material, inprocess/intermediate sample,and finished product by different analytical techniques as per the approved specification/protocol/procedures and Interpret the data from analytical instruments and report the results and submit the completed documents for review promptly.

Role Accountabilities:

To analyze different types of samples as per respective SPEC/SOP/MOA and  report the results

Leadership Capabilities

To work collaboratively with the cross functional team members.

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:
• Sound analytical knowledge
• Hands on experience on the software like TRACKWISE, LIMS. EDMS and good skills in MS Office.
• Ensure safety compliance in daily activities as per Syngene policy and EHSS requirement.
• Overall adherence to safe practices and procedures.
• Contributing to the development of procedures, practices and systems that ensures safe operations and compliance to the company’s integrity & quality standards.
• 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.
• Initiation of QMS elements i.e. Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.
• Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable

Education:

Master’s degree in chemistry/bachelor’s in pharmacy or equivalent

Skill and Capabilities :

• Sampling and analysis of samples as per respective Product Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc.
• Perform pharmacopeial/Regulatory Assessment /surveillance on introduction / revision of new / revised monograph and general chapters/guidelines.
• Analysis of different samples by  LIMS/ELN relevant documentation, testing.
• Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable.
• Maintenance of sampling tools as per the standard operating procedure.
• Preparation of Standard Qualification protocol, Report, protocol  and COA as applicable.
• Archive and retrieve documents related to the working area/section.
• Packing and Maintenance of reserve samples and visual inspection samples as applicable
• Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application software’s
• Calibration of Instruments and to perform HPLC lamp intensity test as per schedule, hot water flushing of HPLC and general preventive checks for laboratory instruments.
• Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
• Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
• Coordination with engineering & maintenance and external vendor for preventive maintenance and calibration activity
• Initiation of Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.
• Disposal of left-over Sample after review/approval of analytical report /Release.
• Adherence to Good Laboratory Practice and Good documentation practices.
• Cleaning of workplace and following Good laboratory practices while working in QC Laboratory.
• Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
• Taking any other job allocated by Head QC / Group Leader /Section Head

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.