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Senior Executive

5-10 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position: QC - Trainee / Jr Executive
Experience Required: 0-1 Year
Location: Hyderabad
Employment Type: Full-Time

Job Summary:

The Quality Control (QC) Technician is responsible for following work instructions and completing all assigned tasks. This position requires adherence to compliance standards and thorough documentation. Strong communication and teamwork are expected from the individual in this role.


Key Responsibilities:

  1. GLP Compliance:

    • Ensure compliance with Good Laboratory Practices (GLP) during all QC activities.
  2. SOP Preparation:

    • Assist in the preparation and review of Standard Operating Procedures (SOPs).
  3. Specification Preparation:

    • Help prepare specifications for raw materials, packaging materials, in-process materials, and finished products.
  4. Standard Testing Procedures:

    • Perform standard testing procedures for raw materials (RM), packaging materials (PM), in-process (IP), finished products (FP), and stability samples.
  5. Stability Studies:

    • Assist in the preparation of stability study protocols and reports.
  6. Sampling:

    • Responsible for sampling raw materials (RM), packaging materials (PM), and other relevant materials.
  7. Change Control & Incident Management:

    • Assist with handling change control, incidents, and CAPA (Corrective and Preventive Actions) processes.
  8. Water System Analysis:

    • Handle analysis and sampling of Purified Water (P.W) and Water for Injection (WFI) systems.
  9. Cleaning Validation Testing:

    • Perform cleaning validation testing and document results accordingly.
  10. Cold Room & Stability Chamber Maintenance:

  • Ensure proper maintenance of stability and cold room chambers.
  1. COA Preparation:
  • Prepare Certificates of Analysis (COA) for finished products.

Key Skills and Qualifications:

  • Educational Requirements:

    • Bachelor’s degree in Science (B.Sc.) or Pharmacy (B.Pharm).
  • Attention to Detail:

    • Strong attention to detail to ensure accuracy in all tasks.
  • Computer Skills:

    • Intermediate computer skills, with proficiency in data entry and report preparation.
  • Multi-tasking and Organization:

    • Ability to multi-task, stay organized, and think on your feet in a fast-paced environment.
  • Communication Skills:

    • Strong written, verbal, and interpersonal communication skills.
  • Mechanical Aptitude:

    • Strong academic foundation with a mechanical aptitude for laboratory processes and equipment handling.