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Job Title: Production Head - Pharma Pellet Manufacturing Facility

Location: SB Organics, Chandapur Village, Hathnoora Mandal, Sangareddy District, Telangana

Company Overview

SB Organics is a WHO-GMP accredited pharmaceutical pellet manufacturing facility dedicated to producing high-quality medicines. We are committed to adhering to the highest standards in manufacturing, ensuring the safety,

efficacy, and compliance of our products with global regulatory standards.

We are seeking a highly skilled Production Head to oversee the operations of our pharmaceutical pellet manufacturing plant. The ideal candidate will be responsible for managing the day-to-day production activities,

ensuring compliance with cGMP, improving operational efficiency, and maintaining the highest standards of quality and safety. The Production Head will lead a team of production personnel, coordinate with other departments, and drive continuous improvement initiatives within the plant.

Key Responsibilities

- Standard Operating Procedures (SOPs):

○ Prepare, review, and update Standard Operating Procedures (SOPs) for all production-related processes to ensure consistency and compliance with GMP standards.

○ Ensure that SOPs are adhered to by all production personnel.

- Master Batch Records (BMR) and Batch Production Records (BPR):

○ Prepare and review Master BMRs and BPRs for all products to ensure accuracy and completeness.

○ Ensure proper documentation and traceability of production batches.

- Production and Manpower Planning:

○ Responsible for planning and overseeing production schedules, ensuring timely and effective completion of production orders.

○ Manage and optimize manpower planning for the production team to meet production targets and maintain productivity.

- Training and Development:

○ Conduct On-the-Job Training (OJT) for newly hired employees, ensuring they understand production processes, SOPs, and safety procedures.

○ Prepare SOP Training Matrix and ensure that all production personnel receive regular training as per the schedule.

- Coordination for Raw Materials and Production Requirements:





○ Coordinate with the procurement and stores departments to ensure the timely availability of raw materials, packaging materials, and other production requirements.

○ Collaborate with cross-functional teams to ensure continuous and uninterrupted production flow.

- Change Control and Deviations:

○ Initiate, review, and execute Change Controls, Deviations, and Document Change Request Forms

(DCRFs) as per the established procedures.

○ Ensure proper documentation and compliance with regulatory guidelines.

- Online Documentation:

○ Ensure accurate and timely completion of online documentation, including BMRs, BPR entries,

equipment logbooks, and temperature and humidity logbooks.

○ Review and verify all production records for compliance with cGMP requirements.

- Equipment Management:

○ Prepare User Requirement Specifications (URS) for new equipment and collaborate with the engineering department for equipment selection.

○ Review Equipment Qualification Protocols and ensure the successful execution of qualification activities.

- Preventive Maintenance and Calibration:

○ Coordinate with the engineering department for the timely execution of preventive maintenance,

calibration, and validation activities for equipment.

○ Ensure all equipment is properly maintained and calibrated to meet production requirements.

- Process Validation:

○ Review and approve Process Validation protocols and reports.

○ Responsible for the execution of Process Validation batches and ensuring compliance with regulatory requirements.

- cGMP Compliance:

○ Ensure that all production activities are conducted in compliance with current Valuable Manufacturing

Practices (cGMP) regulations.





○ Monitor and enforce compliance to cGMP guidelines within the production area.

- Safety and Quality Compliance:

○ Enforce safety guidelines and ensure a safe working environment for all production personnel.

○ Ensure that the production process adheres to quality standards and regulatory requirements.

- Continuous Improvement:

○ Identify and drive continuous improvement initiatives within the production processes to increase efficiency, reduce costs, and enhance product quality.

○ Lead root cause analysis and corrective action implementation for any production-related issues.

- Collaboration:

○ Work closely with other departments such as quality assurance, engineering, and procurement to ensure seamless production operations.

○ Collaborate with the management team to align production goals with the overall objectives of the company.

- Other Duties:

○ Perform any other tasks assigned by the Managing Director or Senior Management to support the plant's operations and growth.

Required Qualifications

● Bachelor's degree in Pharmacy, or a related field. A Master's degree is a plus.

● Minimum 10 years of experience in a pharmaceutical manufacturing environment, with at least 5 years in a leadership role.

● Strong knowledge of GMP regulations, production processes, and pharmaceutical manufacturing practices.

● Experience in preparing and reviewing SOPs, BMRs, BPRs, and other production-related documentation.

● Proven experience in managing production teams and coordinating cross-functional activities.

● Strong understanding of equipment qualification, process validation, and preventive maintenance procedures.

● Excellent organizational, communication, and leadership skills.

Desired Skills

● Proficient in using ERP systems and production management software.

● Detail-oriented with a focus on compliance, quality, and safety.

● Ability to manage multiple tasks and meet deadlines in a fast-paced environment.

● Robust analytical and problem-solving abilities.

Compensation

Competitive salary and benefits package based on qualifications and experience.

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