Junior Officer

Lupin; Panaji; On-site; INR 350,000 - 700,000; Full time

Job summary

Lupin in Goa is seeking a QA professional to ensure cGMP/GxP compliance, complete SOP training, and perform tasks per SOP while reporting deviations to supervisors. The role emphasizes data compilation for the Annual Product Quality Review, stability chamber maintenance, and coordination with engineering and QA teams.

Responsibilities include pulling stability samples as per schedules, logging activities in EDMS, generating master prints from SAP and PAS-X, initiating CAPA and change proposals,

Qualifications

• Graduation in Pharmacy.
• 1 year of work experience.

Responsibilities

• Comply with cGMP, GxP and EH&S regulatory requirements.
• Complete training on SOPs and follow procedures.
• Report any quality concerns or deviations to supervisors.
• Data compilation for Annual Product Quality Review and stability data handling.
• Maintenance and logging of stability chambers and related logs.
• EDMS activities per SOP and master print duties via SAP and PAS-X.
• Initiate and close Change Proposals, Deviations and CAPA in QAMS.
• Ensure EHS compliance and continual improvement of safety practices.

Education

Graduation in Pharmacy

Job description

Job Description:

Job Description

1. Comply with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements.
2. Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
3. Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in following the procedures/instructions to immediate Supervisor/Managers.
4. Report any quality concerns or suggestions for improvements to Supervisors/ Managers.
5. Responsible to complete the assigned trainings, applicable for workgroup “QA - Annual Product Quality Review- and Document management GOA” in the L2LMS (SABA).
6. Data compilation And Statistical trending for Annual Product Quality Review.

9. To coordinate with technical training as a “Departmental Training Coordinator” to meetrequired training compliance of the department.

10. Maintenance of stability chamber in co-ordination with engineering department, and review of temperature data.

11. To place stability samples in the chambers as per stability protocol at various intervals as per procedure specified in the SOP.

12. Timely pullout of samples as per monthly schedule from the stability chambers and to update relevant logbooks, software for login and pull out of stability samples.

13. Maintenance, reconciliation and withdrawal of stability samples charged in stability chamber.

14. Handling of EDMS activities as per SOP SOP_MUM_CQA_000001, Preparation, Review, Approval, and control of Standard Operating Procedures Through Electronic Document Management Systems (EDMS).

15. To take out Master Print of Batch Document through SAP.

16. To take out Master print of Batch Document through PAS-X.

17. Change Proposal, Deviation, CAPA initiation and action plan execution and closure in QAMS.

18. Comply with all EHS responsibilities as follows:

To comply current EHS Management Systems of Site.

To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements and Applicable Legal Compliances.

To carry out all assigned jobs in Safe Manner.

Ensure controls effectively on High Risk Activities / Significant Environmental Aspect & Impact Ensure continual improvement on EHS performance.

Work Experience

1 Year

Education

Graduation in Pharmacy

Competencies

Requirements