Documentation - Production(Api)

1 week ago

Bidar, India Sai Life Full time

**Role**: Documentation
**Department**:Production
**Location**: Bidar

**About Us**: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels.

**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/Chemiscal) with 4-9 years of relevant industry experience.

**Key Competencies (Technical, Functional & Behavioural)**:
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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