Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Production Manager
Job Description
• To manufacture a product that is compliant to SISPQ.
• To ensure GMP and GDP is followed at all levels of manufacturing and relevant activities.
• To coordinate with Projects and Engineering department during commissioning, qualification and maintenance activities.
• Responsible for organizing production schedule to meet the commitment to the supply chain department.
• To evaluate the Risk Analysis for equipment and processes.
• Supporting in managing the resources, planning and ensuring the coordination and control of formulation and filling department.
• To support Validation team to execute the validation and qualification activities as per the pre-approved protocols.
• To ensure the work place and equipment are maintained clean and hygienic all the time.
• To escalate the potential quality events to superiors and take part in investigations and root cause analysis.
• To initiate Change controls related to processes or process equipment pertaining to compounding area.
• To supervise Production operations and ensure the production plan is achieved with respect to quality, quantity, timelines, performance KPIs and HSE standards.
• To supervise, motivate and allow team personnel to develop his/ her competencies and potential in order to perform his/ her job better.
• To support and implement continuous improvements within his/her perimeter.
• To manufacture a product that is compliant to SISPQ.
• To ensure GMP and GDP is followed at all levels of manufacturing and relevant activities.
• To coordinate with Projects and Engineering department during commissioning, qualification and maintenance activities.
• Responsible for organizing production schedule to meet the commitment to the supply chain department.
• To evaluate the Risk Analysis for equipment and processes.
• Supporting in managing the resources, planning and ensuring the coordination and control of formulation and filling department.
• To support Validation team to execute the validation and qualification activities as per the pre-approved protocols.
• To ensure the work place and equipment are maintained clean and hygienic all the time.
• To escalate the potential quality events to superiors and take part in investigations and root cause analysis.
• To initiate Change controls related to processes or process equipment pertaining to compounding area.
• To supervise Production operations and ensure the production plan is achieved with respect to quality, quantity, timelines, performance KPIs and HSE standards.
• To supervise, motivate and allow team personnel to develop his/ her competencies and potential in order to perform his/ her job better.
• To support and implement continuous improvements within his/her perimeter.
Duties & Responsibilities
Operations
• Responsible for Effective Operations of Equipment for compounding and filling area in Insulin facility.
• Ensure operations to be carried with budget planning and its effective utilization.
• To contribute in the definition and execution of the site strategy and is in-charge of implementing Operational Excellence standards (e.g: lean program).
• Supporting in fostering motivation and excellence in his perimeter.
• Responsible for timely support in execution and documentation of validations and other relevant activities.
• Responsible for preparation & Review of SOPs, batch production records and relevant documents pertaining to compounding & filling area.
• Act as a key point of contact for internal and external audit preparations.
• Act as an interface between manufacturing team and cross functional teams during investigations, change approvals, lean management and several miscellaneous activities.
• Improve the existing facility in terms of equipment and practices in compliance with site quality procedures.
• Define ways of working based on the goals and priorities.
• Ensure continuous improvement of Industrial performance in compounding and filling area.
• Simplify ways of working and establish low hierarchy.
• In-line with APU concept, take decisions in given boundaries to meet business requirements.
Operations
• Responsible for Effective Operations of Equipment for compounding and filling area in Insulin facility.
• Ensure operations to be carried with budget planning and its effective utilization.
• To contribute in the definition and execution of the site strategy and is in-charge of implementing Operational Excellence standards (e.g: lean program).
• Supporting in fostering motivation and excellence in his perimeter.
• Responsible for timely support in execution and documentation of validations and other relevant activities.
• Responsible for preparation & Review of SOPs, batch production records and relevant documents pertaining to compounding & filling area.
• Act as a key point of contact for internal and external audit preparations.
• Act as an interface between manufacturing team and cross functional teams during investigations, change approvals, lean management and several miscellaneous activities.
• Improve the existing facility in terms of equipment and practices in compliance with site quality procedures.
• Define ways of working based on the goals and priorities.
• Ensure continuous improvement of Industrial performance in compounding and filling area.
• Simplify ways of working and establish low hierarchy.
• In-line with APU concept, take decisions in given boundaries to meet business requirements.
Training
• Train the staff on compounding operations as per Sanofi group strategy.
• Acquire relevant equipment and process training with respect to compounding and filling relevant operations.
• Prepare the team for various regulatory inspections/ audits and GMP compliance
• Train the staff on compounding operations as per Sanofi group strategy.
• Acquire relevant equipment and process training with respect to compounding and filling relevant operations.
• Prepare the team for various regulatory inspections/ audits and GMP compliance
Cross functional
• Responsible for co-ordinating with QA, QC, Validations, Engineering, HSE and Projects to support in respective relevant activities.
• Support activities conducted by cross functional departments such as HSE, Lean management and facilitate exchange of information.
• Responsible for co-ordinating with QA, QC, Validations, Engineering, HSE and Projects to support in respective relevant activities.
• Support activities conducted by cross functional departments such as HSE, Lean management and facilitate exchange of information.
HSE
• To identify, correct and promptly report unsafe conditions, behaviours, or potentially hazardous situations.
• To animate a strong, proactive culture oriented towards promoting positive behaviours at all times.
• To demonstrate visible commitment to HSE and have the special responsibility to lead by example
• To identify, correct and promptly report unsafe conditions, behaviours, or potentially hazardous situations.
• To animate a strong, proactive culture oriented towards promoting positive behaviours at all times.
• To demonstrate visible commitment to HSE and have the special responsibility to lead by example
Candidate Profile
• Minimum of Bachelor’s/Masters degree in Pharmacy/M.Sc
• Minimum of 7 years’ experience.
• Pharmaceutical industry experience is a must.
• Act for change: Adapt to changing circumstances in positive and enthusiastic manner.
• Cooperate Transversally: Develop and maintain effective cross functional working relationships and partnerships.
• Develop people: Share best practices and expertise to improve team member’s competencies.
• Excellent communication skills.
• Capacity to imbibe new technologies.
• High levels of confidence and problem solving capabilities.
• Knowledge on GMP/ GXP and technicalities involved in manufacturing relevant activities.
• Language requirements: Fluency in English (reading, writing and listening).
• Minimum of Bachelor’s/Masters degree in Pharmacy/M.Sc
• Minimum of 7 years’ experience.
• Pharmaceutical industry experience is a must.
• Act for change: Adapt to changing circumstances in positive and enthusiastic manner.
• Cooperate Transversally: Develop and maintain effective cross functional working relationships and partnerships.
• Develop people: Share best practices and expertise to improve team member’s competencies.
• Excellent communication skills.
• Capacity to imbibe new technologies.
• High levels of confidence and problem solving capabilities.
• Knowledge on GMP/ GXP and technicalities involved in manufacturing relevant activities.
• Language requirements: Fluency in English (reading, writing and listening).
Additional Information
Experience : 5+ years
Qualification : M.Sc, B.Pharm, M.Pharm
Location : Toopran Mandal, Telangana
Industry Type : Pharma
Functional Area : Production
End Date : 25th December, 2018
Experience : 5+ years
Qualification : M.Sc, B.Pharm, M.Pharm
Location : Toopran Mandal, Telangana
Industry Type : Pharma
Functional Area : Production
End Date : 25th December, 2018
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