Senior Officer

Cadila Pharmaceuticals Limited; Ankleshwar; On-site; INR 450,000 - 650,000; Full time

Job summary

Cadila Pharmaceuticals Limited is seeking personnel to manage regulatory documentation and ensure GMP/GDP compliance. Responsibilities include preparing SOPs, URS, BPR, protocols, and investigation reports, maintaining records, archiving old data, and supporting QA submissions.

Position also covers coordinating with QA, QC, PD Lab, Engineering and HR for GMP compliance, and ensuring audit readiness with proper training records and housekeeping in the plant.

Qualifications

• Prepare SOPs/URS/BPR/Protocol/Investigation report for regulatory compliance per procedures.
• Maintain documents/records for regulatory compliance.
• Archive old records and ensure retrievability.
• Check online document submission to QA.
• Raise change control/Deviation/CAPA in OASIS LIMS.
• Support SAP production module transactions as required.
• Raise indents for consumables, parts, stationery and spares.
• Maintain high housekeeping standards in plants.
• Maintain records and GDP/SOP compliance.
• Lead audit preparedness and report deviations to factory manager.
• Maintain training records of employees per training SOP.
• Perform the role of production officer/executive as and when required.
• Coordinate with QA for compliance.
• Coordinate with QC, PD Lab, Engineering and HR for GMP Compliance.
• Coordinate with EHS for safety and environment audits.

Responsibilities

• Produce and ensure compliance-oriented documentation.
• Coordinate with multiple departments to satisfy GMP and GDP standards.
• Assist in audits and regulatory readiness.

Job description

Job Description:

Documentation:

• To prepare SOP’s/ URS/ BPR/ Protocol/ Investigation report for regulatory compliance as per available procedure/practice.
• Ensure that all documents / records required for Regulatory Compliance are maintained properly.
• Ensure old records are archived properly and are retrievable.
• To check online filling of document & online submission to QA department.
• Raise change control/ Deviation/ CAPA in OASIS LIMS.
• To support SAP transaction in production module as & when required.
• Raise indents for Consumables, parts, Stationary and Spares required for the plant.
• To ensure for high standards of housekeeping in plants.
• To maintain all records and documents as per GDP/SOPs.
• To take lead in audit preparedness and report to factory manager in case of any deviation.
• To maintain training records of employees in respect of training SOP.

Production :

• To perform the role of production officer/executive as and when required.

Cross Functional Department:

• To coordinate with QA, department for compliance.
• To coordinate with QC, PD Lab, Engineering and HR etc. for GMP Compliance.
• To coordinate with EHS for safety and environment related audits.

Requirements: