Analyst I Qc Rg Sequencing Jobs

Sample registration and entry in LIMS.

Location: Madhurantakam - Quality Control

Company: Sun Pharmaceutical Industries Ltd

Utilizes knowledge of Nautilus, Analyst, and Dial M software for review of electronic data.

Experience with HPLC, GC, GC-MSD, or LC/MS instrumentation is helpful.

Reviews analytical data to ensure compliance with appropriate SOPs, GLPs, regulatory agency guidelines and client requirements.

Reviews data packets and forms for all study types.

Responds to QA inspection report findings related to QC review of data.

Enters QC dates into CMS.

0-2 years of relevant laboratory experience or experience in a cGMP/FDA regulated industry preferred.

Demonstrated knowledge in Microbiology and aseptic techniques required.

Detail-oriented with strong written and verbal communication skills.

Primary responsibility entails processing samples from the cleanrooms, including non-viable particulate, viable air and surface sampling, and personnel monitoring.

Performs growth promotion of raw materials.

Performs Gram stain and classic microbiology techniques.

Understand and exercise all safety requirements and procedures.

Some laboratory experience in a biological sciences laboratory is preferred.

Possess the ability to manage many tasks and in an organized fashion.

Review and maintain product compliance specifications, documentation control.

Gain proficiency on all testing areas.

Documentation of testing results and determination of aesthetic quality on finished product.

Completes other duties as assigned by Laboratory Management and/or Group Lead.

Demonstrates a working knowledge of the LIMS computer system. Enters data and

Laboratory experience is a plus.

Good practical knowledge of the laboratory environment.

Maintains accurate, complete, legible, and concurrent records of work performed and

Enters results in the laboratory notebook.

Knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.

Alternatively, Master’s degree in above areas with 1 year of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas.

Analytical testing to support product in-process, release, and stability programs.

Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.

Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.

A commitment to Kashiv’s Vision, Mission, and Values is essential.

Maintains all training requirements for assigned tasks

Adhere to QMS policy and regulatory requirements.

EHS Responsibilities – All Associates

Quality Responsibilities – All Associates

We are looking for professionals with these required skills to achieve our goals:

programs as part of the offering.

Other Knowledge, Skills, and Abilities:

Responsible for communicating atypical and out-of-specification results to laboratory management.

Works with supervisor to prioritize activities. Shifts prioritizes to meet business demands. Notifies management when timelines cannot be met.

pharmaceutical industry and with analytical chemistry knowledge. Experience working in a

Demonstrates an understanding of the applicable test methods and a familiarity with compendial testing requirements.

Works independently or in a team setting with minimal supervision. Is accountable for the completion of individual responsibilities.

Required Skills, Knowledge, and Abilities

Effective interpersonal skills when working with others.

Ability to follow the specifics of the chart order.

Input data into computer programs.

Ability to operate, perform user maintenance, and troubleshoot high speed scanners.

Ability to pay attention to detail to ensure documents for the correct patient go in the chart.

Assist management in evaluating and implementing new techniques and technologies with guidance.

At least 0-3 years of related experience or equivalent combination of education & experience.

Work with the reporting Manager to improve and develop outsource testing and stability program functional group.

Preferable, 1+ years’ experience in GxP setting

Experience working in and familiarity with cGMP Part 210, 211,11 and other relevant guidelines preferred

Knowledge of Quality control testing as it pertains to regulatory, compendial and ICH guidelines preferred

Assume project responsibilities and present project updates, experimental plans, timelines, and results in both small and large group meetings.

Excellent interpersonal, written, and verbal communication skills.

Open and willing to learn new skills and techniques as needed.

Experience working in a gene therapy area, especially AAV-based, is a strong plus.

At least 2 years of direct wet lab experience with NGS library preparation protocols and preliminary data analysis.

Hands-on experience with molecular biology methods such as nucleic acid extraction, reverse transcription, PCR, and qPCR/ddPCR analyses.

Perform data entry and peer review for accuracy in accordance with laboratory procedures.

Knowledge of basic laboratory practices required and QC testing methods preferred.

Experience with Sanger sequencing method preferred.

The essential requirements of the job include:

Independently perform sequencing assay according to established standard operating procedures, including primer design, plate set-up, and sequencing result analysis

Use Codon Code Aligner, Snap Gene, and Primer Premier software to complete daily tasks