Job Title: Manager – Packing (US FDA)
Location: Glenmark Pharmaceuticals Ltd., Chhatrapati Sambhajinagar
Job Summary
* Position: Manager – Packing
* Industry: Pharmaceuticals (US FDA regulated)
* Experience Required: 10 to 15 years
* Education: Graduate in Pharmacy (B. Pharm)
* Core Focus: Operational excellence, regulatory compliance, and packaging lifecycle management
Company Overview
Glenmark Pharmaceuticals Ltd. is a leading research-driven, global integrated pharmaceutical company. With a robust presence in the international market, we are committed to delivering high-quality healthcare solutions. We are currently seeking a seasoned professional to join our facility in Chhatrapati Sambhajinagar to lead our Packing department. The ideal candidate will be instrumental in ensuring that our packaging operations align with the rigorous standards set by the US FDA and other global regulatory bodies.
Role Description
As the Manager – Packing, you will oversee the end-to-end packaging processes at our facility. You will be responsible for ensuring that our production lines run efficiently while maintaining strict adherence to safety, quality, and regulatory protocols. This leadership role requires an individual who can balance technical expertise in packaging with strong operational management skills to optimize output without compromising on quality standards.
Key Responsibilities
Packaging Operations and Lifecycle Management
* Lead the packaging department by overseeing day-to-day operations to meet production targets while ensuring the highest level of product integrity.
* Manage the entire packaging artwork approval process, ensuring compliance through the Harmony system.
* Oversee the creation, review, and approval of Batch Packaging Records (BPR) and Standard Operating Procedures (SOP) using OpenText and MSB platforms.
Quality Management and Regulatory Compliance
* Maintain a robust Quality Management System (QMS) within the packaging department, specifically focusing on Change Controls (CC), Deviations, and Corrective and Preventive Actions (CAPA) using the TrackWise system.
* Serve as a primary point of contact during internal and external audits, including US FDA inspections. You must be prepared to demonstrate compliance and present documentation clearly to auditors.
* Facilitate seamless cross-functional coordination with Quality Assurance, Production, Engineering, and Supply Chain departments to ensure a unified approach to manufacturing excellence.
Resource Optimization
* Implement strategies to optimize the utilization of human resources, machinery, and energy consumption.
* Analyze operational bottlenecks and implement process improvements to increase line efficiency and reduce waste.
* Foster a culture of safety and performance, ensuring that the team is well-trained and motivated to achieve operational KPIs.
Required Qualifications and Skills
* Education: A Bachelor’s degree in Pharmacy is mandatory.
* Experience: A minimum of 10 to 15 years of professional experience in the pharmaceutical packaging sector.
* Regulatory Knowledge: Extensive experience in a US FDA regulated environment is essential. Candidates must possess a deep understanding of current Good Manufacturing Practices (cGMP) and global regulatory expectations.
* Technical Proficiency: Hands-on experience with industry-standard software systems such as Harmony, TrackWise, OpenText, and MSB is highly desirable.
* Leadership Skills: Proven track record in managing large teams, handling cross-departmental projects, and driving operational efficiency in a high-pressure manufacturing environment.
* Problem-Solving: Ability to conduct root cause analysis for deviations and implement effective preventive actions to ensure long-term process stability.
Why Join Us?
At Glenmark Pharmaceuticals, we value innovation, integrity, and operational excellence. By joining our team in Chhatrapati Sambhajinagar, you will play a critical role in bringing life-saving medications to patients worldwide. We offer a challenging yet supportive environment where you can refine your leadership skills, engage with global regulatory standards, and contribute to the growth of a leading pharmaceutical organization.
How to Apply
If you are an experienced professional with a background in pharmaceutical packaging and meet the requirements outlined above, we invite you to apply for this leadership position.
To submit your application, please send your updated curriculum vitae (CV) and a cover letter detailing your relevant experience to [email protected]. Ensure that your subject line clearly indicates the position for which you are applying.
We thank all candidates for their interest in Glenmark Pharmaceuticals. Please note that only those selected for an interview will be contacted. We look forward to hearing from you.