Job Description

Job Title:

Senior QA Executive - Formulations

Department:

Quality Assurance

Location:

Cherlapally,Hyderabad

Experience:

4-8 years (Formulation QA)

Qualification:

B.Pharm / M.Pharm/Msc Chemistry

Industry:

Pharmaceutical Formulations (Pellets)

Job Summary:

We are seeking a highly skilled and detail-oriented

Senior Quality Assurance Executive

with strong experience in

pharmaceutical formulations

. The candidate will be responsible for implementing, reviewing, and maintaining

quality systems, documentation, and regulatory compliance activities

, ensuring adherence to

cGMP

and

international regulatory standards

.

Key Responsibilities:1. Documentation & Compliance

Preparation, review, and control of

Standard Operating Procedures (SOPs)

,

Specifications

, and

Master Formula Records (MFRs)

. Preparation and review of

Certificate of Analysis (COA)

and

Method of Analysis (MOA)

for raw materials, intermediates, and finished products. Preparation and maintenance of

Validation Protocols and Reports (VQ/IQ/OQ/PQ)

for equipment and utilities. Review and approval of

batch manufacturing records (BMR/BPR)

and ensuring GMP compliance. Preparation and review of

water system reports

(RO, Purified, and WFI),

environmental monitoring records

, and

microbiological data

. Preparation and submission of

Drug Master File (DMF)

and

supporting technical documentation

for regulatory submissions. Review and approval of

change controls, deviations, OOS/OOT, CAPA

, and

risk assessments

.

2. Validation & Qualification

Support in

process validation

,

cleaning validation

, and

equipment qualification

. Preparation of validation master plan, protocols, and summary reports. Coordination with Engineering and Production teams for execution of validation activities.

3. Quality Systems & Audits

Ensure compliance with

GMP, GLP, GDP, and ISO standards

. Participate in

internal audits

,

vendor audits

, and

regulatory inspections

(USFDA, MHRA, WHO, TGA, etc.). Review and monitor implementation of

corrective and preventive actions (CAPA)

post audits. Maintain and improve

quality metrics

and

documentation control systems

.

4. Training & Continuous Improvement

Conduct periodic training on

SOPs, cGMP, GDP, and documentation practices

. Support continuous improvement initiatives in QA processes and quality systems. Liaise with cross-functional departments (Production, QC, Regulatory Affairs, Engineering, R&D).
Job Type: Full-time

Pay: ₹300,000.00 - ₹700,000.00 per year

Work Location: In person