Deputy Chief Manager - Production (Drug Product)

Piramal Enterprises

0 years

0 Lacs

medak telangana

Posted:2 weeks ago| Platform: Foundit logo

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Skills Required

equipment qualification cgmp regulatory audits process investigations six sigma methodologies

Work Mode

On-site

Job Type

Full Time

Job Description

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.

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