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Junior Team Member - Qa

2+ years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: B. Pharma/ 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

Junior Team Member – QA

Posting Date: February 5, 2025
Country: [Specify]
State: [Specify]
Location: Rangpo
Req ID: 91949

Division: Quality

Department: Quality

Employment Type: Permanent


Job Purpose

The Junior Team Member – QA will be responsible for reviewing compliance levels at the site, preparing master validation protocols and reports, and ensuring adherence to company quality policies and regulatory guidelines. The role includes collating deficiency responses, reviewing documentation, and supporting audits to maintain cGMP compliance and regulatory approvals.


Key Responsibilities

1. Regulatory Compliance & Deficiency Response

  • Collate, review, and prepare work plans for received deficiencies.
  • Coordinate with Head Office (HO) to respond to regulatory authorities on time.

2. Validation & Documentation

  • Review Master Validation Protocols and Reports to ensure timely execution of validation batches.
  • Ensure timely submission of documents in response to deficiencies.
  • Review Annual Product Quality Review (APQR) reports for data completeness and accuracy.

3. Technical Agreements & New Product Execution

  • Manage and issue technical agreements for regulated markets to meet customer requirements.
  • Distribute approval certificates, dossiers (TDP & RAP), and development reports for smooth new product execution.

4. Audit & Inspection Support

  • Coordinate with auditors and site teams for regulatory/customer inspections.
  • Support CDSCO and State FDA inspections to maintain GMP compliance and secure approvals.
  • Prepare compliance reports for audit observations, ensuring alignment with cGMP requirements.

5. Data Review & Continuous Improvement

  • Collect, compile, and review raw data for timely submission of MHRA, UK interim updates.
  • Drive continuous improvement initiatives within Corporate Quality Assurance (CQA).
  • Review and submit product licenses, certificates, and staff approvals to comply with legal requirements.

Qualifications & Experience

Education:

  • B. Pharma / M.Sc

Experience:

  • Minimum 2 years of experience in the Quality Assurance department.

Skills & Competencies

  • Strong domain knowledge in QA processes
  • Collaboration skills for cross-functional coordination
  • Innovative approach to improve compliance
  • Accountability in documentation and reporting
  • Empathy and leadership for quality initiatives
  • Agility in regulatory updates and audits

Job Location: Rangpo

Shift Hours: [Specify]