Officer / Executive R&d (Quality Assurance)

1 week ago


Nagpur, India Ciel HR Services Pvt Ltd Full time

Preparation & review of all Quality Mgt. System related doc.
- Preparation of Validation, Qualification protocols, reports & its review.
- Preparation of SOPs,STPs, Specification ,APQR & Its review
- Preparation & review of Site Master file ,Quality Manual, VMP
- Preparation & updating of documents as per the regulatory standards
- Conduct the vendor audit as per planner
- Handling of market complaint, investigation & CAPA.
- Involvement in Regulatory audits
- Compliance to audits.
- Review & Approval of Regulatory Submission Documents Like PDR, Analytical Method Validations, Stability Protocols & Data, Specifications, Test Methods,
- Dissolution Profiles, MFC, MPC, BMR, BPR, LBR, TBR, Process Validation Protocols/Reports etc.
- Deals in Solid Orals, & Other dosage forms (e.g. Ointment, Gel, Sprays) for US,EU, Brazil, ANZ, ROW and Domestic Markets.
- Planning, Preparation, Review and Evaluation of documents received from

different departments for Regulatory submissions.
- Technical Review of documents and participation in technical discussion to conclude any technical Issues.

**Salary**: ₹400,000.00 - ₹500,000.00 per year

Schedule:

- Day shift
- Evening shift
- Morning shift

Ability to commute/relocate:

- Nagpur, Nagpur - 440013, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)


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