Hpu Qc Executive

1-4 years

Not Disclosed

Bangalore

10 Jan. 30, 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: HPU QC Executive

Job Location: Bangalore
Department: Human Pharmacology Unit
Experience Required: 1 - 4 years

About Syngene

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is a leading integrated research, development, and manufacturing services company. We serve global industries in pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. With a strong workforce of over 4,500 scientists, Syngene is dedicated to delivering high-quality science, robust data management, IP security, and fast-paced manufacturing to help clients improve time-to-market and reduce the cost of innovation. Syngene works with leading biopharma companies, including Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as multinationals like GSK and Merck KGaA.

Job Purpose

The HPU QC Executive is responsible for overseeing the Quality Control (QC) processes within the Human Pharmacology Unit (HPU). This includes performing QC checks for study-related documents, managing study activities per protocol and regulatory guidelines, and supporting the overall quality management system within the unit.

Key Responsibilities

Document Review & QC Checks:
- Perform QC checks of draft Case Report Forms (CRFs) and other study-related documents.
- Ensure that essential documents are filed in Trial Master Files (TMF) and study files at different stages, including pre-study, during study, and post-study activities.
- QC check the transcribed data from source documents with CRF entries and other related documentation.
Study Activities Monitoring:
- Monitor study activities during pre-check-in, check-in, pre-dose, dosing, and post-dose phases, ensuring adherence to protocols, SOPs/IOPs, and regulatory guidelines.
Labeling and Dispensing:
- Provide line clearance and ensure line opening and cleaning for lab technicians to generate labels for Vacutainers and RIA vials.
- Perform similar tasks for dispensing labels in the pharmacy.
Reporting and Trend Analysis:
- Generate Quality Control Reports for study activities or supporting documents.
- Review responses to sponsor/QA observations noted during data review or facility visits, coordinating with the HPU staff and investigators.
- Prepare and present trend analysis reports of observations to the Head of HPU and reporting managers monthly or as required.
SOP & Document Management:
- Review qualification documents and SOPs/IOPs as needed.
- Verify oceasoft and archival processes according to SOP-GCP-HPU-0065.
- Issue true copies of verified calibration/validation reports for display in respective areas.
Facility Systems QC Checks:
- Perform QC checks of HPU facility systems, issuing QC reports and coordinating with relevant department heads for resolution of observations/clarifications.
Other Responsibilities:
- Carry out any other tasks as assigned by the Head of the Human Pharmacology Unit or Head of Syngene Clinical Development.

Qualification

B. Pharma (Bachelor of Pharmacy)

Experience

1 - 4 years of experience in quality control within a pharmaceutical or clinical research environment.

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunities (EEO) to all individuals regardless of age, race, gender, nationality, disability, religion, sexual orientation, gender identity, or any other characteristic protected by law. Reasonable accommodations will be provided for qualified individuals with disabilities.

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Hpu Qc Executive

Job Description

Job Title: HPU QC Executive

About Syngene

Job Purpose

Key Responsibilities

Qualification

Experience

Equal Opportunity Employer

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