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.

📌 Sr Executive Ias Qa Navi Mumbai
🏢 Indoco Remedies
📍 Navi Mumbai