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In-Process Qa - Jr Executive/Executive

0-4 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

Job Title: In-Process QA - Jr Executive/Executive
Experience: 0-4 Years
Location: Hyderabad
Employment Type: Full-Time


Job Summary:

The In-Process Quality Assurance Executive will be responsible for ensuring that all products are manufactured and packaged in accordance with cGMP and other regulatory standards. The position will work closely with production teams to monitor and verify the quality of products throughout the manufacturing process.


Key Responsibilities:

  • Quality Monitoring: Ensure quality is maintained throughout the manufacturing and packaging process, from warehouse to production and final packaging.

  • Regulatory Compliance: Ensure compliance with cGMP and other regulatory requirements for manufacturing and packaging processes.

  • Collaboration with Production Teams: Work closely with production teams to identify and resolve quality issues in real-time, ensuring continuous adherence to quality standards.

  • Investigations & CAPAs: Participate in investigations of deviations and non-conformances, providing support for root cause analysis and corrective and preventive actions (CAPAs).

  • Documentation: Maintain accurate and complete documentation of all quality-related activities, ensuring proper record-keeping in line with regulatory standards.

  • Audits and Inspections: Participate in internal and external audits and inspections, assisting in the preparation of responses to any findings or observations.

  • Training and Guidance: Provide guidance and training to production personnel on quality-related topics, fostering adherence to best practices.

  • Procedure and Policy Development: Contribute to the development and review of quality-related procedures and policies to improve processes.

  • Regulatory Knowledge: Stay up-to-date with the latest regulatory requirements and industry best practices related to in-process quality assurance.


Qualifications:

  • Educational Background: Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, or related field.

  • Experience: At least 1 year of experience in in-process quality assurance within the pharmaceutical industry.

  • Regulatory Knowledge: Strong understanding of cGMP and other regulatory standards for in-process quality assurance.

  • Skills:

    • Excellent problem-solving, communication, and interpersonal skills.
    • Ability to work independently and collaborate in a team environment.
    • Strong analytical and documentation skills.
  • Experience in Audits: Previous experience participating in internal and external audits and inspections is preferred.

  • Root Cause Analysis and CAPAs: Experience in investigations of deviations and non-conformances and supporting root cause analysis and CAPAs.


This role offers the opportunity to work in a fast-paced and regulatory-compliant environment, ensuring the quality of pharmaceutical products from production through to packaging. If you have a passion for quality assurance and are committed to meeting industry standards, we invite you to apply.