Officer/Executive : Quality Assurance -Indeus Life Sciences

Having exposure in preparation of Site Master File, Validation Master Plan, Qualifications & Validation protocols & reports 

Develop and implement defined Quality systems, policies, Guidelines and SOPs for R&D environment pertaining to the activities of Analytical, Formulation and Documentation

Good knowledge of Document Control, Incidence, Deviation, CAPA and OOS investigations.

Strong background of establishing quality systems & compliance thereof.

Ensuring the QbD compliance during the product development.

Conduct QA compliance audits as per applicable standards.

Should interface and support the Formulation Development team during the pre and post scale up operations in reviewing the Pharmaceutical Development reports and its supporting documents.

Review and approve the Analytical method validation protocol and reports, method equivalency study report, and Bio-analytical validation reports etc intended for the regulatory filing.

Should support the development team throughout the product life cycle.

Imparting Training to the scientists on Quality Aspects

Exposure to international audits

* Good auditing and communication skills

* Good knowledge of effective and technical report writing

* Knowledge of CFR, Orange book and other regulatory expectations

Having exposure of preparation & filing of dossiers and technical documents to different regulatory authorities would be beneficial

Well conversant with ISO, GMP, WHO Guidelines and other regulatory requirements for drug products,

M.Sc. / M. Pharm with 3 years work experience

B.Sc. /B. Pharm with 6 years work experience in a regulated environment

Not Disclosed by Recruiter

Pharma / Biotech / Clinical Research

Production, Manufacturing, Maintenance

Production/Manufacturing/Maintenance

Quality Assurance/Quality Control Manager

Quality assurance, GMP, GLP, scale up, deviation, CAPA

(UG - B.Sc - Any Specialization, B.Pharma - Pharmacy) OR (PG - Post Graduation Not Required, M.Sc - Any Specialization, Chemistry, Physics) AND ( Doctorate - Doctorate Not Required)