Sr . Executive - IAS QA

Indoco Remedies; Navi Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Indoco Remedies is seeking a QA/QA In Charge to oversee SOP development, document control, audits and training within the laboratory. The role involves ensuring GMP/QMS compliance, managing calibration and audit processes, and maintaining comprehensive documentation and records across QA functions.

The incumbent will lead internal audits, ensure regulatory alignment with Indian standards, and facilitate timely closure of CAPAs and deviations while training staff on GMP/QMS requirements.

Responsibilities

• Preparing, Reviewing and/or implementing SOPs and department policies.
• Maintaining updated Laboratory directory.
• Issuance and archival of Protocols, Logbooks, Formats.
• Issuance of Training records and various forms (Incidence, Deviation, OOS, Customer complaint).
• Preparing and checking laboratory schedules (Calibration, Preventive Maintenance, Training, Self-Inspection, Data Backup).
• Preparing Site Master File and System Manual.
• Preparing Annual Review Report of the laboratory.
• Reviewing Reports for analysis per Indian regulations/standards and Company policies.
• Review and approval of Protocols, Reports, Calibration certificates, Analyst qualifications and MOA.
• Review of DQ, IQ, OQ and PQ Files for Instruments/Equipments.
• Review of audit trail.
• Creation of User Id for various software of Instruments.
• Review of External calibration certificates.
• Induction and Training of employees.
• Arrange and manage Internal audits.
• Indent logbooks and stationery.
• Prepare calibration certificate of instrument.
• Manage activities related to Internal and External audits.
• Ensure documents required by Customers are provided (Questionnaire, Organogram, Employee Profile, Equipment Master List, Certificates).
• Ensure QMS like Change Control, Deviation Control, CAPA, Incidence Recordings, OOS, OOT, Customer complaints are raised and closed.

Job description

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.