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In-Process Qa - Jr Executive/Executive

0-4 years
Not Disclosed
10 Dec. 5, 2024
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

Job Title: In-Process Quality Assurance Executive

Job Summary:
The In-Process Quality Assurance Executive will be responsible for ensuring that all products are manufactured and packaged in compliance with cGMP and other regulatory standards. This role involves working closely with production teams to monitor and verify the quality of products throughout the manufacturing process.

Key Responsibilities:

  • Ensure quality is maintained from warehouse, to production, and packing stages.
  • Ensure compliance with cGMP and other regulatory requirements for manufacturing and packaging.
  • Collaborate with production teams to identify and resolve quality issues in real-time.
  • Participate in investigations of deviations and non-conformances, providing support for root cause analysis and corrective and preventive actions (CAPAs).
  • Maintain accurate documentation of all quality-related activities.
  • Participate in internal and external audits, providing support for preparing responses to findings and observations.
  • Offer guidance and training to production personnel on quality-related topics.
  • Contribute to the development and review of quality-related procedures and policies.
  • Stay updated with the latest regulatory requirements and industry best practices for in-process quality assurance.

Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related field.
  • At least 1 year of experience in in-process quality assurance in the pharmaceutical industry.
  • Strong knowledge of cGMP and other regulatory standards for in-process quality assurance.
  • Excellent problem-solving, communication, and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Experience in investigating deviations and non-conformances, and supporting root cause analysis and CAPAs.
  • Strong analytical and documentation skills.
  • Experience in participating in internal and external audits and inspections.