Senior Analyst

Syngene International

Bangalore, Karnataka
Permanent
Full-time

2 days ago

JOB DESCRIPTIONJob Title: Senior AnalystJob Location: Syngene International Limited, BengaluruAbout 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 spiritMandatory 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:This is an exciting opportunity to play a role in the Quality control department of Syngene. The role will provide several responsibilities of Analysis, documentation, Lab safety requirements, Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle overall analysis of QC and Stability samples.Role Accountabilities

Analysis of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample/ Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples.
Maintenance of sampling tools as per the standard operating procedure.
Packing and Maintenance of reserve samples and visual inspection samples as applicable
Carry out the analysis on the qualified 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.
Preparation of Certificate of analysis
Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application softwares.
Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
Calibration of Instruments and perform HPLC lamp intensity test as per schedule, hot water flushing of HPLC and general preventive checks for laboratory instruments.
Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable.
Initiation of QMS elements and other documents in Trackwise and EDMS application softwares.
Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
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.
To indent the chemicals, glassware, document, instrument, and accessories required for performing analysis as per the plan.
Archive and retrieve documents related to the section.
Adherence to Good Laboratory Practice and Good documentation practices.
Cleaning of workplace and following Good Laboratories 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.
Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable.
Responsible for taking any other job allocated by Head QC / Group Leader /Section Head/ Section In-Charge.

In addition, the responsibility of the standard management team as;

Receipt, Inventory management, Qualification, Labeling, Dispensing of Analytical standards, removal and disposal of expiry standards and Storage of standards as per the appropriate storage condition used in Quality Control Laboratory.
Review the status of Pharmacopoeial reference standards and their validity periodically.
Preparation of Standard Qualification protocol, Report and COA as applicable.

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

Excellence
Integrity
Professionalism

Specific requirements for this role

Experience
Demonstrated Capability
Education

Experience: 3-6 yearsSkills and CapabilitiesExpertise in handling multiple Instruments/ equipment like HPLC, Dissolution tester, KF, and GC.Capable of thinking scientifically to address complex problems and develop solutions.Work as a team and have a collaborative mindset.Good communication skills.Education: MSC/ B. PharmaEqual Opportunity EmployerIt 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.

Syngene International

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