Senior Executive/Assistant Manager - US QA

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a Sr. Executive / Assistant Manager – US QA in Pune to provide QA support for US-based manufacturing and quality operations.

The role emphasizes cGMP/ICH/FDA compliance for biosimilars and involves batch release, quality systems, validation, and continuous improvement. Candidate should have 7–12 years of QA experience in biologics/biosimilars, with hands-on BMR/CoA review, deviations, CAPA, change control, and a strong data integrity mindset.

Qualifications

• 7–12 years QA experience in biologics / biosimilars.
• Hands-on experience reviewing Batch Manufacturing Records (BMRs) and Certificates of Analysis (CoAs).
• Experience with deviations, CAPA, change control, and quality investigations.
• Strong knowledge of global cGMP, ICH, FDA regulations and data integrity (ALCOA+) principles.

Responsibilities

• Provide QA oversight and support to US-based manufacturing and quality operations.
• Ensure compliance with global cGMP, ICH, FDA regulations across QA activities.
• Review and approve BMRs and CoAs.
• Support deviation investigations, CAPAs, and change control; ensure timely closure per SOPs.
• Participate in risk assessments, root cause analysis, and continuous improvement initiatives.
• Contribute to global harmonization of quality systems and SOPs; support tech transfers and process validation.

Skills

QA oversight

Regulatory compliance

Batch release

BMR & CoA review

Deviations & CAPA

Change control

Technology transfer

Process validation

ALCOA+ data integrity

Cross-functional collaboration

Education

M.Sc

M.Pharm

Job description

Pune, Maharashtra, India

8 - 11 Years

Permanent (ENZBIO)

Job Description

Job Title: Sr. Executive / Assistant Manager – US QA

Experience: 7–12 Years

Qualification: M.Sc / M.Pharm

Job Purpose

To provide QualityAssurance support to US-based manufacturing and quality operations ,ensuring compliance with global cGMP, ICH, and regulatory requirements ,with a strong focus on biosimilars . The role supports batch release,quality systems, validation, and continuous improvement initiatives incollaboration with global cross-functional teams.

KeyResponsibilities

US QA &Compliance

• Provide QA oversight and support to US-based manufacturingand quality operations.
• Ensure compliance with global cGMP, ICH, FDA , and applicable regulatoryguidelines across QA activities.
• Review and approve Batch Manufacturing Records (BMRs) and Certificatesof Analysis (CoAs) .

QualitySystems & Investigations

• Support and review deviation investigations, CAPAs, and change control activities; ensure timely closure in line with internal SOPs.
• Participate in risk assessments , root cause analysis ,and continuousimprovement initiatives .
• Contribute to the global harmonization of quality systems and SOPs .
• Provide QA guidance for technology transfers , processvalidation , qualification , and process improvement initiatives .
• Review and approve SOPs, validation protocols, qualification documents ,and other technical documentation.
• Maintain electronic and paper-based documentation incompliance with ALCOA+ data integrity principles .

QualityMetrics & Reporting

• Monitor and track key quality metrics and KPIs.
• Prepare and present periodic quality reports for US leadershipand stakeholders .
• Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to ensure consistent quality standards.
• Support regulatory inspections, audits, and responses as requiredfor US operations.

Qualification:

Experience:

• 7–12 years of QA experience in biologics / biosimilars

TechnicalSkills

• Strong knowledge of cGMP, ICH, FDA regulations , and global qualitystandards
• Hands-on experience in BMR & CoA review and approval
• Expertise in deviations, CAPA, change control, and quality investigations
• Experience in biosimilars manufacturing, validation, and tech transfer
• Sound understanding of data integrity (ALCOA+) principles