Senior Analyst

3-6 years

Not Disclosed

Bangalore

10 Jan. 28, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Analyst
Department: Analytical Development
Location: Bangalore
Date Posted: 27th January 2025
Education: M.Sc. or M. Pharmacy
Experience: 3-6 years

About Syngene

Syngene is an innovation-driven contract research, development, and manufacturing organization that offers integrated scientific services spanning early discovery to commercial supply. Safety is a top priority at Syngene, with a strong emphasis on adhering to safety guidelines, maintaining a safe working environment, and promoting a culture of health, safety, and environmental responsibility.

Key Responsibilities

Chromatographic and Non-Chromatographic Analysis:
- Perform stability studies and release testing for early-phase GMP departments (drug substance, drug product, intermediates, excipients, etc.) using qualified techniques and adhering to approved specifications/protocols.
- Interpret data from analytical instruments, document results, and submit completed reports within established timelines.
Documentation and Reporting:
- Record analytical observations/findings in data sheets, forms, logbooks, LIMS, and ELN application software.
- Support the preparation of stability summary reports and review final documents.
- Ensure accurate and contemporaneous documentation in a GMP environment, following good documentation practices.
Investigation and Compliance:
- Timely reporting and investigation of any events or deviations to the Department Head and QA function.
- Support investigation processes for clients, ensuring effective and timely closure.
Instrument Calibration and Maintenance:
- Perform calibration of instruments as per the schedule, including hot water flushing of HPLC and general preventive checks for lab equipment.
- Coordinate with engineering, maintenance, and external vendors for preventive maintenance and calibration activities.
Client and Regulatory Audits:
- Actively participate in client and regulatory audits, ensuring adherence to cGMP and GDP guidelines.
Validation and Method Transfers:
- Conduct validation activities and method transfers for multiple client projects.
- Prepare Certificates of Analysis for standards and impurities, as well as reports for Analytical Method Validation and Analytical Method Transfer.
Data and Software Management:
- Create and manage documents, master data, and static data in LIMS, ELN, and LMS software.
- Outsource sample testing when necessary, ensuring proper documentation in respective logbooks.
SOP Preparation and Compliance:
- Support in the preparation of standard operating procedures and upload relevant data in LIMS and other software as per departmental requirements.
Safety Compliance:
- Adhere to safety protocols, using necessary PPE while sampling and analyzing in the lab.
- Ensure safety compliance as per Syngene’s policy and EHSS requirements.
Additional Duties:
- Take on other tasks as assigned by the Head of QC, Group Leader, or designee.

Qualifications and Experience

Education: M.Sc. or M. Pharmacy
Experience: 3-6 years of experience in analytical development, particularly within a GMP environment.

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunities regardless of age, color, national origin, disability, race, gender, religion, sexual orientation, gender identity, marital status, veteran status, or any other characteristic protected by applicable law. Reasonable accommodations are provided for qualified individuals with disabilities.

This revised structure provides clarity in describing the job role and responsibilities, with a logical flow that makes the details easier to follow.s

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Senior Analyst

Job Description

About Syngene

Key Responsibilities

Qualifications and Experience

Equal Opportunity Employer

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