QC Analyst

JOB DESCRIPTION

Job Title: QC Analyst

Job Location: Bangalore

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 :

• Water sampling
• Chemical analysis for water samples
• Environmental Monitoring
• Water sampling
• Lab maintenance and equipment maintenance

Role Accountabilities

• Responsible for Water sampling, Sample receipt of raw materials, in process, finished product and stability samples.
• Responsible for Chemical analysis of different grades of water (PW/WFI/POW) as per the respective specification.
• Responsible for sample management and coordination with team for smooth operation of samples release activity.
• Monitoring and review of Temperature monitoring data record of equipment and clean room. Monitoring of differential pressure in Laboratory.
• 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.
• 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 for Certificate of analysis 
• Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application software
• Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
• Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Software as applicable.
• Initiation of QMS elements and other documents in Track wise and EDMS application software.
• 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/recording the activities contemporaneously and accurately as per Good documentation practices.
• Handling of LMS, LIMS, ELN, Track Wise and EDMS Software for routine activities as applicable.
• 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 Pharmacopoeia reference standards and their validity periodically.
• Preparation of Standard Qualification protocol, Report and COA as applicable.
• Responsible for disinfectant preparation, cleaning, and fumigation of microbiology laboratory.
• Follow the required EHSS policies and good hygiene practice.
• Responsible for taking any other job allocated by HOD / Group Leader/Section Head/ Section In-Charge.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

Experience : 1-3 YEARS

Skills and Capabilities

• Chemical analysis of water, OSD products, Injectable products
• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team
• Good speaking-listening-writing skills, attention to details, proactive self-starter
• Ability to work successfully in a dynamic, ambiguous environment
• Ability to meet tight deadlines and prioritize workloads
• Ability to develop new ideas and creative solutions
• Should be able to work in team and flexible for working in shifts
• Should be a focused employee
• Good documentation capability

Education : B.Sc./M.Sc. Analytical 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.