Deputy Manager-Production ( Drug Product )
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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Deputy Manager-Production ( Drug Product )
Job Description
The incumbent is responsible for ensuring compliance with cGMP requirements and supporting the smooth execution of production operations through effective documentation, quality systems, validation, and compliance activities. The role involves maintaining manufacturing records in compliance with data integrity requirements, coordinating with cross-functional teams, managing GMP documentation, supporting audits, qualification and validation activities, reviewing production records and defect trends, handling SAP, ENSUR, and TrackWise system activities, and driving safety and training initiatives. The position plays a key role in maintaining regulatory compliance, operational excellence, and continuous improvement within the production function.
Job Summary**
We are seeking a highly motivated and experienced Deputy Manager-Production to oversee and optimize drug product manufacturing operations at our state-of-the-art facility. This role involves ensuring efficient production, maintaining quality standards, and leading a team to achieve production targets.
Job Responsibilities**
Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Deputy Manager-Production ( Drug Product )
Job Description
The incumbent is responsible for ensuring compliance with cGMP requirements and supporting the smooth execution of production operations through effective documentation, quality systems, validation, and compliance activities. The role involves maintaining manufacturing records in compliance with data integrity requirements, coordinating with cross-functional teams, managing GMP documentation, supporting audits, qualification and validation activities, reviewing production records and defect trends, handling SAP, ENSUR, and TrackWise system activities, and driving safety and training initiatives. The position plays a key role in maintaining regulatory compliance, operational excellence, and continuous improvement within the production function.
Job Summary**
We are seeking a highly motivated and experienced Deputy Manager-Production to oversee and optimize drug product manufacturing operations at our state-of-the-art facility. This role involves ensuring efficient production, maintaining quality standards, and leading a team to achieve production targets.
Job Responsibilities**
- Supervise and manage all aspects of drug product manufacturing, including compounding, filling, lyophilization, and packaging, ensuring compliance with cGMP regulations and company SOPs.
- Develop and implement production schedules, monitor progress, and troubleshoot any deviations to meet production targets and deadlines.
- Lead, mentor, and train a team of production operators and supervisors, fostering a culture of safety, quality, and continuous improvement.
- Collaborate with Quality Assurance, Engineering, and Supply Chain departments to resolve manufacturing issues, implement process improvements, and ensure timely availability of materials and equipment.
- Conduct investigations into deviations, non-conformances, and CAPAs, identifying root causes and implementing effective corrective and preventive actions.
- Review and approve batch records, production reports, and other relevant documentation to ensure accuracy and completeness.
- Participate in regulatory inspections and audits, providing necessary documentation and support.
- Identify and implement opportunities for process optimization, cost reduction, and efficiency improvement within the production department.
- Ensure all safety protocols and environmental regulations are strictly adhered to within the production area.
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, or a related scientific discipline.
- 5-8 years of experience in pharmaceutical manufacturing, with a minimum of 2-3 years in a supervisory or managerial role within drug product production (sterile or non-sterile).
- Strong understanding and practical application of cGMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in aseptic processing, filling operations, and lyophilization is highly desirable.
- Demonstrated leadership skills with the ability to motivate, develop, and manage a diverse team.
- Excellent problem-solving, analytical, and decision-making abilities.
- Strong communication (written and verbal) and interpersonal skills.
- Proficiency in using manufacturing execution systems (MES) and enterprise resource planning (ERP) software.
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