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SAI Life Sciences
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Executive/Senior Executive - QMS - Production- API - Bidar

Executive/Senior Executive - QMS - Production- API - Bidar

SAI Life Sciences

3 - 8 years

3 - 8 Lacs

bidar

Posted:1 month ago| Platform:

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Skills Required

documentation change control oos api documentation oot qms investigation api production

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role:

Department:

Location:

About Us:

Key Responsibilities

Drafting and Review of Investigation Reports in co-ordination with cross functional departments like Production Blocks, Maintenance, Process Engineering, QA, CQA, PR&D, QC and AR&D etc.
Preparation of Quality Risk Assessment and its Impact Assessment Reports as or when required.
Handling of documents related to Quality Management System (QMS) like Change controls, Deviations, Planned changes, CAPAs etc., as per requirement in co-ordination with cross functional departments like Production Blocks, Maintenance, Process Engineering, QA, CQA, PR&D, QC, AR&D etc.
Follow the cGMP compliance by following the SOPs and approved procedures.
Responsible for any activities assigned by HOD or Senior Management.

Experience/Qualification:

M.Sc/B.Tech/Diploma (Chemistry/Chemical) with 3-8 years of relevant industry experience.

Key Competencies (Technical, Functional & Behavioral):

1. Must have GMP requirement and QMS knowledge.

2. Excellent written communication, interpersonal skills, data analysis and understanding of business processes.

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