Instagram
youtube
Facebook

Sr Quality Assurance Associate (Chennai/Indore)

2+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description: Audit Trail Review & Compliance (Laboratory Instruments)
Company: Endo

Position Summary:

The role involves reviewing audit trails of laboratory instruments, assessing Computer System Validation (CSV) deliverables, and supporting the review of analytical documents and instrument qualification documents. The individual will also be involved in investigating and reviewing laboratory incidents related to audit trails, as well as managing Change Control requests.

Key Responsibilities:

  • Audit Trail Review: Perform thorough reviews of audit trails generated by laboratory instruments to ensure compliance with applicable regulations.
  • CSV Deliverables: Prepare and review Computer System Validation (CSV) deliverables to confirm system integrity and compliance.
  • Empower Software Review: Evaluate message center reports within Empower software.
  • Instrument Qualification Review: Review qualification documents (IQ/OQ/PQ) of laboratory instruments to ensure they meet required standards.
  • Incident Investigations: Investigate and review laboratory incidents related to audit trails, identifying any non-compliance or discrepancies.
  • QMS Action Points: Participate in discussions with the cross-functional team (CFT) to ensure timely closure of QMS action points related to audit trails and system compliance.
  • Change Control Support: Provide support in assessing Change Control requests and ensuring compliance with regulatory and quality standards.

Qualifications:

  • Strong knowledge of software compliance, especially in relation to laboratory instruments and systems.
  • Experience with reviewing analytical documents, qualification documents (IQ/OQ/PQ), and audit trails.
  • Ability to conduct investigations and assess change controls related to audit trails.

Commitment to Diversity, Equity, and Inclusion:

At Endo, diversity is a driving force that unites and empowers the team. We are committed to fostering an inclusive culture where everyone’s unique perspectives are valued, promoting equal opportunities for all. We actively support a diverse environment encompassing race, ethnicity, gender identity, national origin, color, sexual orientation, disability status, age, and other individual qualities.


This position provides an opportunity to work in a regulatory and compliance-focused environment, ensuring laboratory instruments and systems adhere to high standards of accuracy, security, and quality.