Senior Executive Quality Assurance

MSN Laboratories; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

MSN Laboratories in Hyderabad seeks a Senior Executive QA – Biologics to oversee QA activities for biologics manufacturing, ensuring cGMP compliance and adherence to regulatory guidelines.

The role covers upstream, downstream, and fill-finish, training and document management, QMS, deviation investigations, CAPA, and technology transfer.

Candidates should have a Master\u2019s in life sciences and about 5 years' QA experience in biologics or biopharmaceuticals.

Qualifications

• QA oversight for biologics manufacturing including upstream, downstream, and fill-finish processes.
• Oversees batch records (BMRs), SOPs, protocols, and reports for compliance.
• Manages deviation investigations, CAPA, change control, and risk assessments.
• Familiar with FDA, EMA, ICH Q7/Q8/Q9/Q10 guidelines and cGMP.

Responsibilities

• Provide QA oversight for biologics manufacturing operations including upstream, downstream, and fill-finish processes.
• To handle Training management, Document management and QMS.
• Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and validation teams.
• Review and approve validation protocols and reports (process, cleaning, equipment, method validation).
• Support technology transfer activities for biologics processes.
• Manage deviation investigations, CAPA, change control, and risk assessments.
• Provide training on quality systems and regulatory requirements.

Skills

Process development

Quality assurance

Equipment qualification

Process validation

Regulatory guidelines

Documentation review

Quality systems

Training management

Document management

Education

Master’s degree in Biotechnology, Microbiology, Biochemistry, or related life sciences

Job description

Job Summary

Senior Executive QA – Biologics is responsible for overseeing quality assurance activities related to biologics, manufacturing, ensuring compliance with cGMP, regulatory guidelines (FDA, EMA, ICH), and company quality standards.

Key Responsibilities

Provide QA oversight for biologics manufacturing operations including upstream,

downstream, and fill-finish processes.

To handle Training management, Document management and QMS.

To handle development quality assurance activities.

Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.

Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.

Support technology transfer activities for biologics processes.

Manage deviation investigations, CAPA, change control, and risk assessments.

Ensure accurate documentation practices (GDP).

Review and approve validation protocols and reports (process, cleaning, equipment, method

validation).

Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and

validation teams.

Provide training on quality systems and regulatory requirements.

Qualifications

Education:

Master’s degree in Biotechnology, Microbiology, Biochemistry, or related life sciences.

Experience:

o Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceutical

industry, with experience in biosimilars, biologics

o Required Skills

Process development Quality assurance.

Handling of equipment qualifications and process validations.

Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).

Strong documentation review and quality systems management.

Handling document management and training management.