Gm Operations-pharma Plant

2 weeks ago

Dera Bassi, India JS Jobs Solution Pvt Ltd Full time

**Scope**: Managing P&L of pharmaceutical unit, its operations, production/ productivity, ensuring quality & regulatory affairs.

**Desired profile**:
**Qualification**: B. Pharma/ M. Pharma

**Experience**: Minimum 20 yrs of experience in managing large scale projects from conceptualization to commissioning & day to day plant operations with any of reputed pharmaceutical company managing P&L, regulatory & audits.

**Exposure**: Must have minimum 5-7 years of plant management experience. Regulatory audits facing experience and good technical knowledge of production and quality processes.

**Role & Responsibilities**:

- Managing plant operations of Oral Solids & Liquids, Injectable, Dry Syrup & Ointment products, & maintenance of the manufacturing facility.
- Ensuring productivity, quality, cost, service and safety targets for the manufacturing units.
- Ensure planned KPI’s of efficiency and performance are met or exceeded.
- Subject Matter Expert (SME) at site to review the investigations and identify root cause(s)/ corrective and preventive actions associated with all day to day major to critical Quality Management System elements (OOS, Deviations, Market Complaints, OOT, Rejections and like to like Non-Conformance)
- Conceptualizing, creating/ modifying, implementing, monitoring, maintenance, re-view & upgrade operational procedures.
- Managing P& L related aspects of SBU of Pharma formulations plant with effective utilization of resources, minimization of the yield loss and processing waste at various stages of manufacturing.
- Managing operations of formulations, Branded and Generics
- Implement and drive continuous improvement activities through the implementation of change management processes and best practices.
- Managing regulatory audits.
- Ensure complete compliance to prescribed QMS, cGMP processes.
- Identifying gaps in Systems vs Practices as well as regulations vs systems and their timely remediation/ updating in a holistic manner
- Regulating requirements in Engineering, Utility, Warehouse, Production (OSD/Liquid/Ointment/ Injectable etc.), QMS and IT Controls
- Plays active role in conducting and managing inter/ intra departmental self-inspections
- Skilled in keeping the systems/ procedures and practices aligned with the current regulatory norms w.r.t manual as well as electronic forms.
- Accountable for the online compliance and readiness of site to various external inspections.
- Ensuring adherence to cGMP standards of all applicable regulatory /customer standards and expectations and meeting to continuous improvement in system, practices and documentation.
- Must have exposure to regulatory audits such as UK (MHRA), South Africa (MCC), PICS, Uganda, (NDA), Zimbabwe MOH (MCAZ), Tanzania (TFDA), ANVISA (Brazil), TGA (Australia), Russia, Canada, Romania, WHO & CDSCO approvals

**Salary**: ₹2,500,000.00 - ₹4,000,000.00 per year

Schedule:

- Day shift

Ability to commute/relocate:

- Dera Bassi, Punjab: Reliably commute or planning to relocate before starting work (preferred)

Work Location: In person

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