Senior QA Executive

Nitika Pharmaceutical Specialities; Nagpur District; On-site; INR 600,000 - 900,000; Full time

Job summary

Nitika Pharmaceutical Specialities in Nagpur seeks an Executive / Senior Executive for Quality Assurance (QMS/Validation). The role focuses on ensuring cGMP and regulatory compliance, preparing and reviewing APQR, validation reports, SOPs, and BMR, and managing the QMS. You will handle batch documents, analytical reports, and customer queries.

UG/PG pharma and related diplomas are required, with relevant QA experience in pharma manufacturing preferred.

Qualifications

• UG degree in Pharmacy or Diploma in Pharma/Polymer Technology.
• Postgraduate degrees in Bio-Chemistry, Chemistry or Environmental Science.

Responsibilities

• Ensure compliance with cGMP, Indian FDA, WHO-GMP, US FDA, ICH, EU-GMP, ISO.
• Preparation & review of APQR, validation reports, SMF, SOPs, BMR.
• Manage QMS.
• Review batch documents and analytical reports.
• Handle product complaints, customer queries.

Education

B.Pharma

Diploma in Pharma

Polymer Technology

MS/M.Sc in Bio-Chemistry

MS/M.Sc in Chemistry

MS/M.Sc in Environmental Science

Job description

Executive / Senior Executive - Quality Assurance (QMS/Validation)

Responsibilities

• Ensure compliance with cGMP, Indian FDA, WHO-GMP, US FDA, ICH, EU-GMP, ISO.
• Preparation & review of APQR, validation reports, SMF, SOPs, BMR.
• Manage QMS.
• Review batch documents and analytical reports.
• Handle product complaints, customer queries.

Role Category

Quality Assurance – Other

Education

• UG: B.Pharma in any specialization, Diploma in Pharma, Polymer Technology.
• PG: MS/M.Sc. in Bio-Chemistry, Chemistry, Environmental Science.