Quality Executive

Krsnaa Diagnostics Ltd.; Kangra, Shimla district, Chamba; On-site; INR 500,000 - 900,000; Full time

Job summary

Krsnaa Diagnostics Ltd. seeks a QA professional to uphold the Quality Policy and ensure QM and QSP compliance across all lab operations.

The role includes internal audits, license monitoring, NABL training support, SOP maintenance, instrument calibration checks, and MIS reporting to drive quality improvements while safeguarding confidentiality and lab integrity.

Qualifications

• NABL knowledge and compliance
• Familiarity with QA/QC and SOP management
• Understanding of QM and QSP principles
• Ability to maintain calibration records

Responsibilities

• Ensure Quality Policy is understood and implemented at all levels.
• Prepare and review QM, QSP, PSCM documentation and IQC/EQC reviews.
• Conduct scheduled internal audits across all departments and centers.
• Monitor and ensure laboratory licenses are up to date.
• Participate in secondary audits by CROs/pharma and take corrective action on NCs.
• Support staff with technical queries and ensure instrument validations.
• Check reagent documentation and maintain SOPs list.
• Oversee in-house NABL training and competency assessments.
• Assist in NABL documentation for sister labs and collection centers.
• Prepare MIS QA reports and develop quality plans with QM/Director-operations.
• Advise on quality improvement initiatives and calibration records management.
• Maintain calibration records for general instruments and ensure lab integrity.
• Promote teamwork and ensure adherence to the lab's JD; avoid conflicting activities.

Job description

• To assure that Quality Policy is understood, implemented and maintained at all levels in the organization.
• To assure that the requirement of QM and QSP are implemented and maintained
• To prepare QM, QSP, PSCM, to review IQC and EQC.
• To conduct scheduled Internal audits of all departments (at all centres).
• To monitor laboratory licenses.
• To participate in Secondary Party Audits by CROs and pharmaceuticals and take corrective actions of the NC’s arising.
• To constantly support staff for any technical queries.
• To check for instrument validations.
• To check for reagent documentation.
• To maintain a current list of all SOP’s.
• To be responsible for In-house NABL training and competency assessment.
• To provide advice and help sister labs in preparation of documentation for NABL.
• To audit sister labs and collection centres to monitor NABL preparations and reviewing corrective actions for the NC’s as per schedule.
• To prepare MIS report of QA.
• To devise quality plan & policy with consent of QM & Director-operations.
• To advice on Quality improvement plan.
• To conduct In-house calibration of thermometers and maintaining records.
• To maintain calibration records of general instruments.
• Ensuring good camaraderie between colleagues and contribute to achieve the lab goals.
• Individual should not be involved in any activities outside the scope of their JD which would harm confidence in the laboratory’s competence, impartiality, judgement or operational integrity.

Confidentiality & Ethical Conduct:

• Confidentiality of information pertaining to every client is maintained.
• All clinical samples should be handled as per legal requirements and protocols set by the organization.
• If there is conflict in competing interests, they should be appropriately declared.
• Individual should be free from any adverse influence such as commercial, financial or other pressures that may affect their quality of work.
• Individual should not be involved in any activities outside the scope of their JD which would harm confidence in the laboratory’s competence, impartiality, judgement or operational integrity

GENERAL RESPONSIBILITIES:

• Participate in all activities which seek to ensure compliance with Lab Accreditation.
• Continual update of knowledge.
• Compliance at all times of Safety Manual.
• Ensure any error that affects safety at work is escalated to designated supervisor.
• Shall maintain the decorum of the laboratory and follow the HR policy.
• Shall be flexible with shift timings if required in case of inadequate staff