Assistant Manager - Quality Assurance

Why This Role Matters

Batch Release is one of the most critical checkpoints in pharmaceutical and vaccine manufacturing. It ensures that every manufactured batch meets predefined quality, safety, and regulatory standards before being released to the market.
At Biological E. Limited, the Assistant Manager – QA (Batch Release) plays a vital role in safeguarding product integrity and regulatory compliance within the vaccines business. This position directly impacts patient safety and global supply reliability.

Job Description

Biological E Limited is seeking an experienced Quality Assurance professional for its Shamirpet facility to manage batch release activities within the QA department.
The role involves review and approval of batch manufacturing records (BMR), batch packaging records (BPR), analytical reports, deviations, change controls, and ensuring compliance with GMP and regulatory requirements prior to final batch disposition.

Key Features of the Role

• Independent responsibility for batch release decisions
• Interaction with Production, QC, and Regulatory teams
• Exposure to vaccine manufacturing and biologics QA
• Regulatory-compliant documentation oversight
• Critical quality decision-making authority

Responsibilities

• Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
• Verify analytical reports, in-process controls, and finished product testing data
• Evaluate deviations, OOS, OOT, and change control documentation
• Ensure compliance with cGMP, internal SOPs, and regulatory guidelines
• Authorize batch disposition for commercial distribution
• Coordinate with QC and Production for closure of quality observations
• Participate in internal and external audits
• Maintain QA documentation and batch release registers
• Support regulatory inspections and responses
• Ensure timely batch release without compromising compliance

Required Qualifications

• 7–9 years of experience in Quality Assurance
• Strong hands-on experience in batch release activities
• Experience in vaccines/biologics manufacturing preferred
• Good knowledge of cGMP, regulatory guidelines, and documentation practices

Educational Requirements

• Bachelor's degree of Pharmacy
• Master's degree of Pharmacy

Experience and Skills

• In-depth knowledge of batch record review
• Understanding of deviation management and CAPA
• Familiarity with regulatory inspection requirements
• Strong documentation and analytical skills
• Attention to detail and decision-making capability
• Ability to work under timelines with accuracy
• Good cross-functional coordination skills

Salary Insights

• Competitive mid-management compensation
• Growth opportunities within QA and regulatory functions
• Exposure to vaccine quality systems and global regulatory standards

Location Details

Department: Quality Assurance
Function: Batch Release
Location: Shamirpet, Hyderabad

Company Overview

Biological E. Limited is a leading Indian vaccine and biologics manufacturer with strong global presence. The organization is known for its commitment to quality, regulatory excellence, and large-scale immunization programs.

The QA team plays a crucial role in ensuring that every vaccine batch released meets international quality standards.

FAQs

Q: Is vaccine experience mandatory?
Preferred, but strong batch release experience in regulated pharmaceutical manufacturing is essential.

Q: Does the role involve regulatory inspections?
Yes, support during audits and inspections is part of the responsibility.

Q: Is this an individual contributor role?
Primarily yes, but coordination across departments is required.

Application Tips

• Highlight number of batches reviewed/released per month
• Mention regulatory inspections handled (USFDA, WHO, etc.)
• Showcase deviation/OOS handling experience
• Emphasize GMP and documentation expertise