Executive/Sr Executive For Formulation -DQA

Biophore; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Biophore India Pharmaceutical Pvt Ltd invites applications for the Formulation DQA (Development Quality Assurance) department. The role requires 3–6 years of relevant experience in formulation QA and a strong foundation in QMS, SOP compliance, and audits.

You will review development and CQA documents, participate in method validation and transfers, ensure GMP/GLP/GDP compliance, conduct internal and external audits, and coordinate trainings.

Qualifications

• 3–6 years of experience in Formulation DQA.
• Experience in IPQA and Analytical QA (OSD/Injectable).

Responsibilities

• Handling of QMS documents and Ensure the SOP compliance
• Review of Formulation Analytical Development Documents & Formulation Product Development Documents.
• Method Validation and Transfer Protocols and Reports
• Product development with QbD approach
• Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs.
• Review of FRD activities (LNBs, BDRs, PDR's, MFR's and MPR')
• SOP's and Guidelines Preparation and Review and Approval of SOP's.
• Responsible for conducting Internal Audits/External Audits for Cross functional
• Departments in Formulation Division and External Division.
• Conducting and Coordinating Employee Trainings.
• Responsible for Review and Approval of Vendor Qualification
• Should have experience in IPQA and Analytical QA (OSD/Injectable)

Skills

QMS documents

SOP compliance

GMP/GLP/GDP

IPQA

Analytical QA

Job description

Dear Applicants,

Greeting from Biophore India pharmaceutical Pvt Ltd,

We have opening for Formulation DQA Department - Development Quality Assurance

Job description -3 - 6 Yrs

• Handling of QMS documents and Ensure the SOP compliance
• Review of Formulation Analytical Development Documents & Formulation Product Development Documents.
• Method Validation and Transfer Protocols and Reports
• Product development with QbD approach
• Responsible for ensuring GMP/GLP/GDP compliance in the Formulation and Analytical areas as per the respective SOPs.
• Review of FRD activities (LNBs, BDRs, PDR's, MFR's and MPR')
• SOP's and Guidelines Preparation and Review and Approval of SOP's.
• Responsible for conducting Internal Audits/External Audits for Cross functional
• Departments in Formulation Division and External Division.
• Conducting and Coordinating Employee Trainings.
• Responsible for Review and Approval of Vendor Qualification
• Should have experience in IPQA and Analytical QA (OSD/Injectable)