Assistant Manager - DQA ( Analytics): Biologics

Kemwell; Nelamangala; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Kemwell is seeking an Asst. Manager in Development/Research Quality Assurance with 6-9 years of relevant experience in India. The role focuses on delivering DQA activities across Process, Analytical Development Labs, including document and analytics reviews.

Responsibilities include data analysis for critical reports, collaboration with PD scientists, and supporting deviation reviews, CAPA plans, and SOP enhancements as part of a quality-focused development team.

Qualifications

• 6-9 years of experience in data analytics and Quality Assurance.
• Education: BTech/MSc/MTech/M Pharm.

Responsibilities

• Review technical documents in Upstream, Downstream, and Analytical Development.
• Analyze data for critical reports such as consistency and tox batches.
• Collaborate with PD scientists to review critical documents.
• Support PD personnel in deviations, change management, and CAPA plans.
• Enhance SOPs related to DQA in partnership with PD personnel.
• Act as a Subject Matter Expert from DQA for investigation of major deviations.

Skills

Data analytics

Quality Assurance

Documentation review

CAPA handling

SOP enhancement

Cross-functional collaboration

Education

BTech/MSc/MTech/M Pharm

Job description

we are looking for a Asst. Manager in Development/Research Quality Assurance with 6-9 years of relevant experience. this role will focus on delivering all DQA-related activities in Process, Analytical al Development Labs, particularly the review of technical documents and analytics.

Key Responsibilities include:

• Reviewing technical documents in Upstream, Downstream, and Analytical Development.
• Analyzing data generated for critical reports such as consistency batches and tox batches.
• Collaborating closely with PD scientists to ensure thorough reviews of critical documents.
• Supporting PD personnel in reviewing deviations, change management, and CAPA plans.
• Enhancing current SOPs related to DQA in partnership with PD personnel.
• Acting as a Subject Matter Expert from DQA for the investigation of major deviations.

Qualifications:

• Education: BTech/MSc/MTech/M Pharm.
• Experience: 6-9 years in data analytics and Quality Assurance.