Sr . Executive - IAS QA

Role & responsibilities

• Preparing, Reviewing and/or implementing Standard Operating Procedures and department policies and procedures.
• Maintaining updated Laboratory directory as and when changes takes place.
• Issuance and archival of Protocols, Logbooks, Formats, etc.
• Issuance of Training records, Incidence Investigation report, Change control form, Deviation form, OOS Investigation form, Customer complaint form, etc.
• Preparing and checking laboratory schedules like Calibration Schedule, Preventive Maintenance Schedule, Training Schedule, Self-Inspection Schedule, and Data Backup Schedule etc.

Preparing Site Master File and System Manual.

• Preparing Annual Review Report of the laboratory.
• Reviewing Reports for analysis, as per the relevant Indian regulations/standards and Company policies/Standards.
• Review and approval of Protocol, Report, Calibration certificate, Analyst qualifications and MOA, etc.
• Review of DQ, IQ, OQ and PQ Files for Instruments/Equipments.
• Review of audit trail.
• Creation of User Id for various softwares of Instruments.
• Review of External calibration certificates.
• To assure the proper Induction and Training of employees.
• To arrange and manage and perform Internal audits.
• To indent logbooks and stationary.
• To prepare calibration certificate of instrument.
• To manage activities related to Internal and External audits.
• Ensure that documents required by Customers are given to them (like Questionnaire, Organogram, Employee Profile, Equipment Master List, Certificates etc.)
• To ensure that QMS like Change Control, Deviation Control, CAPA, Incidence Recordings, OOS, OOT, Customer complaints, etc. are raised as and when required and then closed at appropriate time.

• Preparing Audit compliance reports.
• To monitor and perform all the activities of QA In charge in his absence.
• To ensure GLP compliance in laboratory.
• Impart training to workmen and staff on GMP requirements and QMS requirements.
• Handling of DMS, TRACKWISE and LIMS software.
• Performs other related duties as required and directed.