Location
Chennai | India
Job description
M. Pharm/ B.Pharm. having 8+ years of experience in sterile / formulation unit. Candidate should have an experience and strong exposure in regulated markets and skills in facing / handling regulated audits. Candidate should have a knowledge and experience in Aseptic operation and manufacturing of products.
Responsibility :
- Responsiblefor preparation and implementation of production related SOPs.
- Responsiblefor preparation and review of new BPRs, BMRs and validation protocols.
- ImplementingcGMP in the shop floor and conducting training to team of technical andnon-technical staffs and workers.
- Responsiblefor planning the day to day activities as per production task.
- Responsiblefor maintaining the quality of product by adhering to the regulatory norms andprocedure.
- Responsiblefor performing/monitoring the core activities as per the validated profile andrecord in the respective logbook.
- Responsiblefor inter-department co-ordination with QA, QC, Packing, Warehouse andEngineering.
- Responsiblefor manufacturing and execution of products as per cGMP requirements.
- Responsiblefor production related investigation with the root cause analysis, correctiveaction and implementation.
- Participatein customer/regulatory audits related to CSL.
- Responsiblefor overall maintenance of production related equipment s and instruments.
- Candidatesmust be self-motivated with excellent written and verbal communication skills.
- Candidateshaving injectable / Formulation background are highly preferred.
Job tags
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