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· Responsible for preparation and implementation of production related SOPs.
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· Responsible for preparation and review of new BPRs, BMRs and validation protocols.
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· Implementing cGMP in the shop floor and conducting training to team of technical and non-technical staffs and workers.
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· Responsible for planning the day to day activities as per production task.
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· Responsible for maintaining the quality of product by adhering to the regulatory norms and procedure.
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· Responsible for performing/monitoring the core activities as per the validated profile and record in the respective logbook.
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· Responsible for inter-department co-ordination with QA, QC, Packing, Warehouse and Engineering.
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· Responsible for manufacturing and execution of products as per cGMP requirements.
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· Responsible for production related investigation with the root cause analysis, corrective action and implementation.
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· Participating in customer/regulatory audits related to CSL.
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· Responsible for overall maintenance of production related equipment’s and instruments.
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Candidates must be self-motivated with excellent written and verbal communication skills.
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Candidates having injectable / Formulation background are highly preferred.