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• To ensure delivery of products in time of desired quality and quantity.
• To ensure continuous improvement in achievement of productivity , manufacturing yields & quality norms .
• Overall responsible and accountable for the safe operation of plant with in statutory guidelines and regulations
• To ensure that plant machinery , material and people are always working in safe environment by periodic safety audits and compliance to governing statutes
• To ensure timely submission of reports and documents to management /external authorities.
• To manage industrial relations with in the plant and handle sub ordinate grievance
• To ensure that the resources are available for optimal operation of all departments .
• To ensure better co-ordination with departments to meet the day-to-day activities.
• To co-ordinate with the other departments like regulatory affairs, R&D, corporate quality assurance, purchase, global supply chain and other corporate dept. like safety, finance, etc . for efficient and smooth functioning of plant.
• To sign and review various documents like application to authorities, contracts, technical documents as site
Head.
Quality
• To ensure that production department and area is maintained in ATR (all time readiness) for any internal, CQA, customer or regulatory audits.
• To ensure that production procedures are designed to meet the Sun Pharma , customer and regulatory guidelines.
• To ensure that these procedures are followed in production area and unplanned deviation and documentation errors are controlled.
• To demonstrate compliance to established Manufacturing operations and QS standards.
• Timely reporting to the management of incidences I quality issues, statutory notices, safety incidences or any other such occurrences that may affect organizat i on's legal status, goodwill or quality system.
To support QA Department in routine investigations, incidence reporting, deviations, change controls, market complaints and other various quality improvement plans .
• To review I approve process deviations, change controls, validation I qualification protocols, site master file, validation master plan, gate pass and other relevant plant related documents.
• To take all measures as may be deemed fit to produce quality products and take preventive measures for controlling internal errors on shop floor and market complaints .
• To strive for reduction in OOS, deviations and market complaints.
• To face audits and arrange to take corrective & preventive measures to mitigate observations and submit response in stipulated time and report findings/ observations to senior management.
• To be an active member of Quality Review Board & Chairperson for the Quality System Management
Review meetings at the site.
• Document Integrity : To support compliance of practices to established procedures and GMP standards.
Delivery
• To ensure timely error free deliverance of products as per plant production plan with optimum utilization of resources like man, machine and materials etc .
• To ensure new product launches in time 100%.
• To keep the team in a state of high motivation and discipline to deliver with the fullest potential.
• To apply innovative methods and systems to improve productivity levels and reduce waste.
• To identify bottlenecks of facility I equipment I capacity and plan for resolution of the same by way of modification etc.
• To identify and procure new machines /equipment and to modify machines, facilities, etc.
• To ensure meaningful and science based technology transfer of new products from R&D to plant for commercial production and maintenance throughout its lifecycle .
Cost
• To ensure that the plant is operated with in the approved budgets.
• . To ensure overall cost effectiveness in all operations by optimal utilization of resources.
• To ensure maintenance of inventories at plant and timely disposal of non-moving, expired or rejected materials from the plant.
People Development
• Creating a culture/environment which motivates employees to grow being part of organization .
• To ensure that all employees working at site are adequately trained before they participate in any activity and training activities are monitored for compliance and to improve efficiency/productivity.
• To mentor and develop subordinates w.r.t. cGMP to ensure meeting current regulatory requirements at site.
• To create quality culture by encouraging people to comply to set procedures and all incidences get reported, investigated and brought to its logical conclusion.
• To plan for continuous improvement through training and development.
• To develop talent pipelines for IeveiiI, Ill & IV key jobs, succession planning for G10 & above positions.
• To keep updated of latest regulations and arrange to implement the same at facility proactively .
• To identify high potential candidates and develop them by giving them opportunity to grow i n their career path.
Measurement - Implement measurement matrix, conduct review meetings for Gangtok.
30% of the time
Job Scope
Internal Interactions (within the organization)
External Interactions (outside the organization)
Geographical Scope
Financial Accountability (cost/revenue with exclusive authority)
Job Requirements
Educational Qualification
M.Sc / B.Pharm / M.Pharm
Specific Certification
Skills
Experience
20 + Years of experience
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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