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Senior Research Associate -Ad

0-2 years
Not Disclosed
10 Jan. 8, 2025
Job Description
Job Type: Full Time Education: M.Pharm / M.Sc 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 Research Associate - AD

Location: Ahmedabad, Gujarat, India


Job Overview

The Senior Research Associate - AD will be responsible for conducting analytical testing and ensuring compliance with GLP (Good Laboratory Practice), GDP (Good Documentation Practices), and data integrity practices in the laboratory. The role includes performing routine analysis of raw materials, packaging materials, in-process, finished products, and stability samples, along with the calibration of analytical instruments and the preparation of technical documents such as SOPs, specifications, and validation reports.


Key Responsibilities

Laboratory Analysis & Testing

  • Perform sampling of raw materials and packaging materials in accordance with SOPs.
  • Conduct routine analysis of raw materials, packaging materials, in-process, finished products, cleaning swabs, and stability samples.
  • Carry out calibration of analytical instruments.
  • Perform method validation and verification activities.
  • Routine analysis of clinical and stability samples.

Documentation & Compliance

  • Prepare technical documents, including SOPs, specifications, COA (Certificates of Analysis), STP (Standard Testing Procedures), and validation protocols/reports.
  • Archive and retrieve system documents, such as instrument logbooks and registers.
  • Report analytical data and submit for review and release.
  • Ensure compliance with GxP standards (GMP, GDP, etc.) for all processes.
  • Maintain a hygienic condition in the respective department.

Qualifications

  • Education:

    • M. Sc. in Pharmaceutical Organic Chemistry/Analytical Chemistry or
    • M. Pharma
  • Required Skills:

    • Proficient in method validation and verification activities.
    • Knowledge in routine analysis of clinical and stability samples.
    • Strong understanding of GLP, GxP (GMP, GDP), and data integrity practices.
    • Ability to prepare and maintain technical documents in a compliance-driven environment.
    • Familiarity with analytical techniques and instruments.

About Us

Piramal Pharma Solutions (PPS) is a global Contract Development and Manufacturing Organization (CDMO) offering comprehensive services across the drug life cycle. We serve customers with a globally integrated network of facilities, specializing in various sectors, including drug discovery, process development, and manufacturing of APIs, biologics, and finished dosage forms.


Equal Employment Opportunity

Piramal Group is committed to providing equal employment opportunities to all individuals. We do not discriminate based on race, ethnicity, religion, gender, disability, or any other legally protected characteristic. We base employment decisions on merit, skills, and qualifications.


Join Our Team

If you are passionate about ensuring quality and compliance in pharmaceutical research and enjoy working in a collaborative and regulatory-compliant environment, apply for the Senior Research Associate - AD position today!