PURPOSE To: Execute downstream/ Upstream manufacturing unit operations; ensure documentation and compliance Within:
GMP , regulatory and organization guidelines With the objective of producing products in defined terms of volumes and timelines, while ensuring compliance to quality standards, GMP and other regulatory and statutory requirements, as per schedule.
Execute unit operations within DS/UPS as per the BPR ; Conducts activities in support of production schedules; Obtains and stocks supplies as required and under supervision; Prepares media / buffers and solutions as required for the unit operation , Perform routine cleaning and support activities in GMP Manufacturing areas, including routine process area cleaning, autoclave operation, manual cleaning and sterilization of components and parts; Monitors processes and results and suggest methods to ensure process success ; Interfaces with process automation systems
IN ORDER TO execute unit operations as per the production specification and yield requirements.
Compliance & Documentation Issues
discrepancies and work with cross-functional departments to close the discrepancies and implement appropriate corrective actions; Comply with all relevant GMP, safety standards and SOPs of the operation of designated manufacturing equipment. Complete batch documentation in compliance with GMP. Collection and maintenance of data in accordance with cGMPs, company standards, policies and other regulatory requirements; Supports team in effective and timely completion of root cause investigations and CAPA
IN ORDER TO ensure effective and efficient production operations across all plants.
Maintaining manufacturing equipment to ensure correct functionality and calibration compliance. Operation of manufacturing equipment and automated systems within the validated process parameters ; Support qualification and validation activities
IN ORDER TO ensure that the batch runs on a qualified equipment.
Safety & Facility Inspection :
Actively promote safety awareness and improvements; Proactively engage in continuous improvement activities; Adhere to the company’s safety rules and conduct all work in a manner report all unsafe matters and near miss /accidents.
IN ORDER TO ensure safe and hazard free production operations.
Attach updated resume and mention your
- Recent 2019/ 2020 – Total annual CTC
- Expected CTC
- Notice Period.
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