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. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Production Specialist
• To manufacture a product that is compliant to SISPQ.
• To follow GMP and GDP at all levels of manufacturing and relevant activities.
• To work along with Projects and Engineering department during commissioning, qualification and maintenance activities.
• To support Validation team to execute the validation and qualification activities as per the Pre-approved protocols.
• To maintain the work place and process equipment clean and hygienic all the time.
• To escalate the potential quality events to superiors.
• To perform sampling as per sampling plan and procedures.
Duties & Responsibilities
• Responsible for executing Insulin compounding and filling activities.
• Operate the equipment pertaining to compounding and filling activities.
• To support or suggest for continuous improvements pertaining to processes.
• Responsible for project support and validation support such as effective installation, commissioning, qualification/ validation of equipment in compounding and filling area.
• Responsible for executing various operations of compounding and filling area for Insulin Project.
• Support in preparation of Compounding and filling related SOPs, PPTs, training matrix and consumables list.
• Ensuring timely cleanliness of area and equipment of Compounding and filling area.
• In-line with APU concept, follow the instructions from superiors and facilitate in meeting business requirements.
• Do critical trouble shooting in consultation with head of production, i.e. when sterility assurance could be compromised due to breakdown or severe malfunctions.
• Acquire relevant equipment and process training with respect to Compounding and filling of Insulin and relevant operations.
• Responsible to support for various regulatory inspections/audits and adhere to GMP compliance.
• Acquire knowledge and training on internal and external audits.
• Responsible for coordinating 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.
• Safety` PEP talk implementation
• Identify and report unsafe act, unsafe condition and near miss.
• Ensure timely Incident reporting, lead investigation and CAPA implementation.
• Workplace Risk assessment and active participation in HSE trainings.
• Ensure adherence to HSE procedures and appropriate PPE’s are donned during maintenance and handling of chemicals activities.
• Effective LEX communication to reduce and prevent recurrences.
• Ensure strict adherence to work permit system and manage high risk activities by following Sanofi Life Saving Rules.
• Qualification: Minimum of Bachelor’s degree in applied sciences.
• Minimum of 3 years’ experience.
• Pharmaceutical industry experience is required.
• This position requires working in shifts.
• Stretch: Constantly look ways to apply learnings and drive improvement.
• Take action: Keep Sanofi nimble by simplifying as i go.
• Act for patients & customers: Always look at what is best for our patients and customers in any solution that I work on.
• Think Sanofi first: Help colleagues across the organization to be successful.
• Good communication skills.
• Adaptability to new technologies and techniques.
• Good 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).
Experience : 3 years
Qualification : Bachelor’s degree in applied sciences
Location : Toopran, Telangana
Industry Type : Pharma
Functional Area : Production
Job ID : R2613739
Last date : 30th November, 2021
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