Officer

SUN PHARMA; Pakke-Kessang; On-site; INR 450,000 - 650,000; Full time

Job summary

Qualified candidates will hold a B.Pharma with at least 2 years of production experience in tablet manufacturing, and be authorized to sign as an officer. Strong leadership and GMP training skills are expected to drive compliance and efficiency.

Qualifications

• B.Pharma degree with 2+ years of production experience in tablet manufacturing.
• Authorized to sign as an officer.
• Knowledge of cGMP documents and documentation control.
• Strong coordination with QA, QC, and other departments.
• Ability to train staff and maintain GMP compliance.

Responsibilities

• Oversee day-to-day production activities in the Tablet department (FBE section).
• Ensure GMP compliance and quality in production records and logs.
• Coordinate with QA, QC, Warehouse, MIS, and Engineering for schedules and validations.
• Prepare BMR, SOP, Protocols for new products/machines; revise as needed.
• Lead calibration, validation activities, and procurement of spares and equipment.
• Maintain GMP documents, training records, and housekeeping records.

Skills

GMP compliance

Calibration

Validation

Documentation

Team management

Education

B.Pharma

Tools

BMR/SOP/Protocol

Job description

Job Description:

Qualification : B.Pharma

Experience – 2+ years of experience

He Is Authorize To Sign (as An Officer)

• cGMP documents as per following but not restricted to Equipment sequential log, Temperature and %RH record, Daily, weekly and Monthly cleaning records of Manufacturing area, Balance calibration, In process and under test approval label, Tool set cleaning record, Tool set utilization record etc.

Batch manufacturing Records. In process and Finished Product Test Requisitions.

Bulk quarantine / Staging room In-out record.

• The Officer is responsible for overall production activities of the Tablet department (FBE section) on day to day basis in achieving total production requirements in quantity, quality and GMP compliance in department and Execution of production activity. To assist other Officer in manufacturing and controlling the functions related to Tablet department.
• To assist establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow established / new procedures, maintaining and updating existing procedures in the department.
• Responsible to co-maintain, coordinate for validation and GMP in all departments along with the Quality Assurance officer and to coordinate with Quality control department in matters relating to product quality.

• Responsible for Good Manufacturing Practice/training to staffs and operator in the all department.
• Responsible for optimization of the resources namely men, material and machine in respective department.
• Make daily reports on day to day activities concerning the department.
• Responsible for Calibration, qualification and validation activity of respective equipments or products.
• Indenting and procurement of machineries, change parts, spares and material required in respective department.
• Destruction note preparation and execution.
• Maintaining the GMP documents like equipment logbooks, records of physical monitoring and housekeeping records.
• Training the subordinates and manpower to meet the organizational goals and achieve GMP compliance.
• Help the subordinates into standardize production activities to achieve better efficiency and product quality.
• The Officer will handle the responsibility of Officer in his absence.
• Coordinate with related departments like with Warehouse & MIS for the materials to achieve schedule plan, with the Engineering department for preventive maintenance schedule.
• BMR/ SOP/ Protocol preparation for the new product/New machines. Revision of BMR / SOP /

Protocol whenever required and execution of BMR/ SOP/ Protocol.

Requirements: