General Manager, Plant Management

Amneal Pharmaceuticals

Description

JOB DESCRIPTION

Responsible to look after overall plant activities i.e. Regulatory Compliance and Quality Control, Strategic Planning and Management, Production Management, Financial Management, Human Resources and Team Management, Health and Safety, Process Improvement and Innovation, Customer and Stakeholder Relations, Reporting and Communication, Risk Management and Contingency Planning.

Essential Functions

Ensure the plant adheres to Good Manufacturing Practices (GMP) and industry standards.
Troubleshoot and address any production bottlenecks, equipment malfunctions, or supply chain issues
Ensure compliance with local, national, and international regulations (e.g. USFDA etc.).
Cost-effective solutions without compromising on product quality or safety
Lead, motivate, and manage plant staff, including production, maintenance, quality control, and support teams.
Foster a collaborative work culture and ensure a high level of employee engagement.
Ensure the plant complies with occupational health and safety standards.
Lead initiatives aimed at reducing waste and improving sustainability practices.
Communicate effectively with all departments, ensuring transparency and alignment of objectives.
Responsible for day to day functioning of manufacturing and packing functions of Matoda site.
To ensure that products are produced and stored according to the approved documents in order to obtain required quality
To approve the instructions relating to production operations and to ensure their strict implementation.
To ensure that the production records are reviewed and signed by an authorized person before they are sent to the Quality unit.
To check the maintenance of the department, premises and equipment and ensure that the manufacturing facilities/equipment are maintained.
To plan & execute the trial, pilot, exhibit batch manufacturing and validation activities as per the requirement of the organization and approved procedures with in required time lines.
To ensure that all the departmental activities and related processes are carried out as per cGMP requirements & safety requirements in manufacturing, packing and warehouse departments.
To ensure timely preparation, review, implementation & revision of all facility and product related documents and related formats as and when required.
To ensure prompt review and coordinate for qualification, re-qualification, calibration, preventive maintenance activities of the departmental equipment/ facilities.
To proactively identify CGMP compliance issues and arrange for taking prompt corrective measures.
To ensure that appropriate process and other validations are carried out as per protocols.
To ensure optimal staffing of the functions for which the responsibility is assigned as mentioned above and they are trained and qualified personnel.
To ensure identification of training needs and implement, plan and co-ordinate for initial and continuous trainings of entire staff including supervisors, technicians/ operators.
To ensure training to departmental personnel related to technical, behavioral & GMP requirements.
To regularly update knowledge in regulatory requirements, technical processes and ensure departmental personnel are also updated with the same.
To ensure Material & manpower planning for execution of the manufacturing activities.
To co-ordinate with all departments such as QA, Regulatory affairs, Product development, Analytical research & development, Human resource, Purchase, Finance, Marketing, Corporate supply chain, Projects and IT department for day to day departmental requirements and activities.
To support QA in Continuous process verification, investigation & recommendation of CAPA for any OOS, Market Complaint & Deviations, with required review process for the effectiveness of CAPA.
To review change controls of manufacturing and packing.
To actively participate in internal audits program and undertake continuous improvement of the facility, systems and processes.
To fulfill all audit compliances from internal & external agency with required corrective and preventive actions.
To identify the bottlenecks in manufacturing and regulatory compliance and plan for removal of the same so as to have continuous improvement in the processes.
To prepare the Annual budget for the department and maintain department operations within the assigned budget.
To ensure safety of all employees and arrange to train people in practicing safety procedures in the manufacturing, and warehouses.
To ensure discipline in the areas of responsibilities and keep the personnel in high motivation to follow systems and procedures of the organization.
Additionally responsible for planning of manufacturing and project related work of Amneal Pharmaceuticals Pvt. Ltd, at SEZ for Oral Solids.
To act on any other directions as defined or delegated by the management.

Additional Responsibilities

QUALIFICATIONS

Education

Bachelors Degree B. Pharm - Required
Master Degree M. Pharm - Preferred

Experience

Other in More than 20 Yrs

Specialized Knowledge: Licenses: