Deputy General Manager Operations

Company Description

Theon Pharmaceuticals Ltd., part of the renowned Theon Group of Companies, is a leading pharmaceutical organization committed to innovation, quality, and global health advancement. Based in Himachal Pradesh, the company operates a state-of-the-art WHO-GMP and ISO 9001:2008 certified production facility with an impressive capacity for tablets, capsules, injectables, and dry syrup formulations. Serving over 60 countries with more than 500 product registrations, Theon Pharmaceuticals specializes in third-party contract manufacturing and is equipped with cutting-edge technology, including a Dry Powder Injectable manufacturing facility. With a focus on adhering to stringent cGMP and international regulatory standards, Theon Pharmaceuticals continues to expand its global footprint and deliver high-quality pharmaceutical solutions worldwide.

Position Level

Department:

Location:

Position Summary

The Site Head / Production Head for Injectables will lead and oversee all manufacturing operations at the injectable facility, ensuring compliance with US FDA and EU GMP standards. This role is pivotal in managing the end-to-end production process, from raw material procurement to final product release, while maintaining high-quality standards and operational efficiency.

Qualifications

· Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or a related field.

· Minimum of 15 years in pharmaceutical manufacturing, with at least 5 years in a leadership role overseeing production.

· In-depth knowledge of US FDA and EU GMP regulations; additional certifications in quality management systems are a plus.

· Strong leadership, communication, and problem-solving skills; proficiency in production planning and resource management.

Key Responsibilities

1. Operational Leadership:

· Oversee the entire injectable manufacturing process, including formulation, filling, lyophilization, and packaging.

· Ensure production schedules are met, optimizing resource utilization and minimizing downtime.

· Implement lean manufacturing principles to enhance productivity and reduce waste.

2. Quality & Compliance:

· Ensure strict adherence to US FDA and EU GMP regulations, including Annex 1 for sterile medicinal products.

· Lead the preparation and execution of regulatory inspections and audits.

· Manage the implementation of Corrective and Preventive Actions (CAPAs) and deviations.

3. Regulatory Affairs:

· Maintain up-to-date knowledge of global regulatory requirements and ensure site compliance.

· Coordinate with regulatory agencies for product approvals and submissions.

· Oversee the preparation of regulatory documentation and filings.

4. Team Management:

· Lead, mentor, and develop a multidisciplinary team, fostering a culture of continuous improvement.

· Manage staffing levels, training programs, and performance evaluations.

· Promote cross-functional collaboration to achieve organizational goals.

5. Financial & Resource Management:

· Develop and manage the site’s budget, ensuring cost-effective operations.

· Oversee procurement and inventory management of raw materials and consumables.

· Implement strategies to optimize resource utilization and reduce operational costs.

6. Safety & Environmental Compliance:

· Ensure compliance with Environmental, Health, and Safety (EHS) regulations.

· Promote a safe working environment through regular training and audits.

· Address and resolve any safety concerns promptly.

Key Performance Indicators (KPIs)

· Compliance audit scores and inspection outcomes.

· Production yield and efficiency metrics.

· On-time delivery and customer satisfaction levels.

· Cost per unit and overall operational cost reductions.

· Employee training completion rates and safety incident reports.