Executive - Quality Assurance, Pharma

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

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

Key Responsibilities

1. 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.

1. 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

1. 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

1. Documentation Control:

• a. Preparation and Review of SOPs
• b. Controlled distribution and archival of documents & record
• c. Control of master documents

1. Assuring quality of products by :

• a. Ensuring SOP compliance
• b. Review of Batch Manufacturing & Packing Records
• c. Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
• d. Ensuring the effectiveness review of the implemented CAPA

1. cGMP Training:

• a. To prepare training modules and organize training in GMP
• b. Execute the training program in coordination with all concerned departments

1. Other:

a. Review of maintenance and calibration program.