Quality Assurance Personnel- Glp

3-4 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: Quality Assurance Personnel - GLP
Location: Bangalore
Date Posted: 27th January 2025
Experience: 3-4 years
Education: Post-graduation in Pharmacology / Biotechnology

About Syngene

Syngene is an innovation-driven contract research, development, and manufacturing organization offering integrated scientific services, ranging from early discovery to commercial supply. Syngene places a strong emphasis on safety, making it an integral part of both personal and professional conduct, and ensuring adherence to safety guidelines, procedures, and SOPs.

Core Purpose of the Role

The primary responsibility of this role is to ensure compliance with the Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP) and meet the ICH and NABL ISO 17025:2017 testing requirements.

Key Responsibilities

Compliance and Documentation Management:
- Ensure compliance with GLP, OECD, ICH, and ISO 17025:2017 standards.
- Review and approve study-related documents, including SOPs, study plans, study reports, and other quality assurance documents.
- Maintain copies of approved study plans and general documents.
Change Control, Deviation Management, and CAPA:
- Handle change controls, deviations, and Corrective and Preventive Actions (CAPA) processes.
- Perform audits of study raw data and study reports to ensure adherence to GLP standards.
Inspection and Audits:
- Perform or schedule inspections for toxicology and mutagenicity studies, ensuring compliance with GLP guidelines.
- Conduct audits on study raw data, study reports, and computerized system documentation, with specific attention to OECD 17 and 21 CFR Part 11.
Safety and Training:
- Ensure adherence to environmental, health, and safety (EHS) requirements in the workplace.
- Participate in training programs related to EHS measures and ensure the team meets mandatory safety training deadlines.
Quality Data Management:
- Prepare data for quality meetings and contribute to compiling quality analytics for monthly meetings.
SOP and Document Review:
- Review and/or prepare SOPs, study plans, and other documents related to the Quality Assurance Unit (QAU).
- Review general documents, SOPs, study plans, and study reports for adherence to required standards.

Skills and Capabilities

Strong commitment to work with high levels of dedication, motivation, and the ability to persuade in a team setting.
Excellent speaking, listening, and writing skills, with attention to detail and a proactive approach to work.
Ability to work effectively in a dynamic and ambiguous environment, meeting tight deadlines and prioritizing workloads.
Creative problem-solving abilities and innovative thinking.
Ability to work in a team and flexibility in working shifts.

Education and Experience

Education: Post-graduation in Pharmacology / Biotechnology.
Experience: 3-4 years of experience in Quality Assurance with a focus on GLP compliance.

Syngene Values

Employees are expected to demonstrate alignment with the following core values:

Excellence
Integrity
Professionalism

Equal Opportunity Employer

Syngene is an equal opportunity employer, committed to providing a work environment free from discrimination. The company offers equal employment opportunities to all individuals regardless of race, gender, disability, age, national origin, or any other legally protected characteristic. Syngene also ensures reasonable accommodations for qualified individuals with disabilities.

This structure provides clarity on the role’s responsibilities, required qualifications, and values, with a concise flow of information.

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Quality Assurance Personnel- Glp

Job Description

About Syngene

Core Purpose of the Role

Key Responsibilities

Skills and Capabilities

Education and Experience

Syngene Values

Equal Opportunity Employer

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