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Quality urance Executive

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Job Location drjobs

Job - France

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

Job Title: Quality Assurance Executive
Department: Quality Assurance
Salary: 17K 25K
Location: Bavla

Experience: 1 Year

Job Responsibilities:

  1. Review of SOPs and GMP Documents:
    • Review and ensure the accuracy and compliance of all departments Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP) documents.
  2. Preparation of QA SOPs:
    • Develop and update Standard Operating Procedures (SOPs) specific to the Quality Assurance department.
  3. Pharma Cloud Software Expertise:
    • Utilize and manage pharmaceutical cloud software related to Quality Assurance to ensure efficient documentation and process management.
  4. InProcess Quality Assurance (IPQA) Activities:
    • Perform inprocess checks during the manufacturing and packaging stages of tablets capsules and liquid formulations.
  5. Sampling Activities:
    • Conduct sampling activities for tablets capsules liquids and gummies in compliance with SOPs and GMP standards.
  6. SOP Compliance:
    • Ensure all Quality Assurance department activities comply with established SOPs and regulatory guidelines.
  7. Validation Protocols and Reports:
    • Prepare review and ensure compliance with validation protocols and reports as per regulatory and company standards.
  8. Qualification Documents:
    • Prepare and review qualification documents related to equipment systems and processes.
  9. Sampling for QC Analysis:
    • Perform sampling of rinse and swab samples and coordinate with the Quality Control (QC) department for testing.
  10. Documentation Review:
    • Review Master Control Manufacturing (MCM) Master Control Packaging (MCP) Master Formula Record (MFR) Master Packaging Record (MPR) Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) to ensure accuracy and compliance.
  11. Batch Record Review:
    • Review batch manufacturing and packaging records to ensure compliance for batch release.
  12. Internal Audit and SelfInspection:
    • Conduct internal audits and selfinspections to ensure compliance with SOPs GMP and regulatory requirements.
  13. Document Issuance:
    • Prepare and review SOPs issue relevant logs and ensure proper documentation issuance to all respective departments.
  14. Training System Management:
    • Ensure the QA training system is uptodate and manage the training of all departments and new employees.
  15. Document Issuance and Tracking:
    • Oversee the issuance of documents and track QA department trainings as per the training matrix.
  16. Additional Responsibilities:
    • Perform any other activities allocated by the Head of Department (HOD) as required.

Qualifications and Skills:

  • Bachelors degree in Pharmacy Chemistry or a related field.
  • Indepth knowledge of GMP SOPs and quality management systems.
  • Proficiency in pharmaceutical cloud software.
  • Strong attention to detail and ability to work independently.
  • Excellent communication and documentation skills.
  • Ability to conduct internal audits and handle regulatory inspections.

Note: Transportation will be provided to and from Pakwan Cross Road Ahmedabad.

Remote Work :

No

Employment Type

Full Time

Company Industry

About Company

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