Job Description

Job Summary:

The Quality Assurance Officer - Injections is responsible for ensuring that sterile injectable products are manufactured, tested, and released in compliance with cGMP, regulatory requirements, and company quality standards. The role focuses on aseptic operations, documentation review, deviation handling, and maintaining sterility assurance throughout the product lifecycle.

Key Responsibilities:

GMP & Compliance

Ensure compliance with

cGMP

,

WHO

,

FDA

, and local regulatory requirements for sterile products Review and approve

Batch Manufacturing Records (BMRs)

and

Batch Packaging Records (BPRs)

for injections Perform

line clearance

and

in-process checks

for aseptic filling, lyophilization, and sealing operations
Sterile Operations Oversight

Monitor and review

aseptic processes

, cleanroom practices, and gowning procedures Review

environmental monitoring

(air, surface, personnel) data and trends Ensure proper handling of

sterilization processes

(autoclave, dry heat, filtration)
Documentation & Investigations

Review and approve

SOPs, protocols, and validation documents

related to injections Initiate, investigate, and close

deviations, OOS, OOT, and CAPA

related to sterile manufacturing Participate in

risk assessments

and root cause analysis (RCA)
Validation & Qualification

Support

process validation

,

media fill (aseptic process simulation)

, and cleaning validation Assist in qualification of equipment, utilities, and cleanrooms (IQ/OQ/PQ)
Audits & Regulatory Support

Participate in

internal audits

, vendor audits, and regulatory inspections Prepare and provide documentation during inspections by health authorities Support implementation of audit observations and corrective actions
Training & Continuous Improvement

Conduct GMP and aseptic behavior training for production and QA staff Promote continuous improvement and quality culture within sterile manufacturing areas
Qualifications & Experience

Education

Bachelor's degree in

Pharmacy, Microbiology, Biotechnology, Chemistry

, or related field Master's degree is an advantage
Experience

3-5 years

of experience in Quality Assurance or Quality Control in

sterile injectable manufacturing

Hands-on experience with aseptic processing and sterile documentation
Required Skills & Competencies

Strong knowledge of

sterile manufacturing and aseptic techniques

Familiarity with

media fills, environmental monitoring, and sterility assurance

Excellent documentation and analytical skills Understanding of regulatory guidelines (WHO, FDA, cGMP) Attention to detail and strong decision-making ability
Job Types: Full-time, Permanent

Pay: ?400,000.00 - ?500,000.00 per year

Benefits:

Cell phone reimbursement Provident Fund
Work Location: In person