Position Title: Executive I - Quality Assurance, Pharma

Qualifications & Experience
Educational Qualification
Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.

Experience
1–5 years of relevant experience in Pharma Quality Assurance / Documentation

Skills & Competencies
Robust knowledge of cGMP, GDP, and Quality Systems
Hands-on experience with batch documentation and document control systems
Positive understanding of APQR preparation and regulatory expectations
Solid analytical, organizational, and coordination skills
Effective communication and cross-functional collaboration abilities
Attention to detail and commitment to data integrity

Key Responsibilities
Quality Management/Continuous Improvement
a. Line Clearance and shop floor compliance
b. Carry out in-process checks and calibration of IPQC instruments.
c. Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system.
d. Assisting in Complaint Investigation system at site
e. Assisting in Qualification and validation system, change control system,



deviations
f. Preparing & review the Annual Product Quality Review
g. Review of Batch Manufacturing & Packing Records
h. Coordination of cGMP Training activity.
Compliance
Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
i. Understanding the requirements
ii. Performing the Gap analysis to find out the gaps in existing system
iii. Preparing a compliance plan for closure of gaps
iv. Execution of compliance plans
v. Review of completion for compliance activity
Validations & Qualifications:
a. Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes
b. Review of protocols for qualification and validation of facility/ equipment / product / process
c. Review of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
a. Preparation and Review of SOPs
b. Controlled distr

📌 Executive Quality Assurance, Pharma Ankleshwar (India)
🏢 Zentiva Group
📍 India