Job Description

Quality Assurance Officer is responsible for ensuring that all manufacturing and quality-related activities comply with

Good Manufacturing Practices (GMP)

,

regulatory guidelines

, and

company quality standards

. The role involves reviewing documentation, monitoring production processes, conducting internal audits, and supporting continuous improvement to maintain product quality and regulatory compliance.

Key Responsibilities:

Review

Batch Manufacturing Records (BMR)

,

Batch Packing Records (BPR)

, and other related documents before batch release. Monitor in-process activities in the production and packing areas to ensure compliance with GMP and SOPs. Participate in

line clearance

,

in-process checks

, and

documentation verification

. Review and ensure implementation of

Standard Operating Procedures (SOPs)

and update them as required. Handle and document

deviations, change controls, CAPA

, and

OOS/OOT investigations

in coordination with relevant departments. Conduct and support

internal audits

,

self-inspections

, and

vendor audits

to ensure compliance with quality standards. Ensure the proper

qualification and calibration

of equipment, instruments, and utilities. Participate in

training programs

and ensure proper documentation of staff training records. Assist in

validation and qualification

activities (process, cleaning, equipment, and analytical methods). Ensure data integrity and documentation accuracy in all QA operations. Support preparation for regulatory and customer audits (e.g., WHO, USFDA, MHRA, GMP). Promote a culture of continuous improvement and compliance within the organization.

Qualifications & Experience:

Education:

B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, or related field).

Experience:

Around

3 years

of experience in Quality Assurance within a

pharmaceutical formulation / API / sterile manufacturing unit

.

Technical Skills:

Strong understanding of

GMP

,

GLP

, and

regulatory requirements

(WHO, USFDA, EU-GMP). Experience with

documentation control

,

CAPA

,

change control

, and

deviation handling

. Familiarity with

validation and qualification protocols

.

Soft Skills:

Excellent attention to detail and documentation accuracy. Strong communication and coordination skills. Ability to work cross-functionally with production, QC, and maintenance teams. Good analytical and problem-solving skills.

Key Performance Indicators (KPIs):

Timely review and approval of production and quality documents. Number of deviations/CAPA closed within target timelines. Compliance rate during internal and external audits. Reduction in documentation errors and non-conformities. Adherence to GMP and company quality systems.
Job Type: Full-time

Pay: ?15,000.00 - ?35,000.00 per month

Benefits:

Paid sick time Paid time off Provident Fund
Work Location: In person