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- Responsible for the overall operations and activities of the Drug Product Plant.
- Oversee production and manpower planning for the Drug Product Plant.
- Ensure products are manufactured and stored as per approved procedures and documentation to maintain quality standards.
- Review and ensure execution of Batch Production Records (BFR, BPR, etc.) as per cGMP requirements.
- Ensure qualification of equipment and instruments is carried out as per schedule.
- Ensure product validations are conducted in line with regulatory requirements.
- Monitor and maintain minimum stock of consumables, logbooks, and status labels.
- Ensure preventive maintenance of equipment as per the defined schedule.
- Coordinate with service departments (QA, QC, Stores, SCM, EHS, E&M) for production-related activities.
- Attend GMP and safety trainings and implement training outcomes at the workplace.
- Ensure initial and continual training of department personnel is conducted and updated as per need.
- Oversee production-related inputs in SAP and ensure timely FG transfers.
- Lead investigations of market complaints and quality incidents.
- Investigate market complaints, deviations, and quality incidents, and implement effective CAPA against root causes.
- Participate in management reviews on process performance, quality, and drive continual improvements.
- Ensure timely and effective communication and escalation of quality issues to the appropriate management levels.
- Ensure production activities are executed as per predefined procedures and cGMP guidelines.
- Ensure audit readiness and compliance with stipulated timelines.
- Ensure compliance with legal, statutory, ISO, and OHSAS requirements.
- Identify and evaluate risks, hazards, and environmental aspects and review them periodically.
- Develop and monitor objectives and targets under ISO and OHSAS standards.
- Identify SHE training needs and ensure awareness and competence among department personnel.
- Act as department lead in the absence or authorization of senior management.
- Possess knowledge and hands-on experience in serialization.
- Possess knowledge and hands-on experience in equipment qualification.
- Demonstrated experience in independently handling regulatory audits.
- Hands-on experience in process investigations, deviations, and handling customer complaints.
- Knowledge and practical experience in Lean and Six Sigma methodologies.
Qualifications
Qualification: B.Pharm / M.Pharm / M.Sc / B.Tech ( Chemical ) (or equivalent).Experience: 15–20 years in Drug Product manufacturing / Formulation with exposure to regulatory environments.Strong leadership, communication, and people management skills.Proficient in SAP and other manufacturing-related systems.
Required Skills
BFR , BPR , qualification of Equipment's & instruments , GMP , CAPA , QMS Process investigation, deviations, and customer complaints Serialization , Equipment qualification , Regulatory Audits . Six sigma methodology.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.Job Info
- Job Identification 9357
- Job Category Production
- Posting Date 08/29/2025, 05:42 AM
- Apply Before 10/31/2025, 05:42 AM
- Degree Level Bachelor's Degree
- Job Schedule Full time
- Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN
