IPQA Executive

Job Title: In-Process Quality Assurance Executive

Location: Mehsana, Gujrat

About [Company Name]:

Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter/manufacturer based in India. The company provides it products and services in multiple countries globally including West Africa, East Africa, South Asia, South East Asia, the Middle East, South America & Europe. Apart from promoting our branded products in the retail sector, we also participate in a number of global tenders in a number of countries. The team comprises of a group of first generation marketing expats and some of the best technocrats in the field. The company has four manufacturing bases in India, manufacturing a variety of products.

This job posting is in a hormone formulation manufacturing division of Celogen Pharma.

Job Summary:

We are seeking a highly motivated and meticulous In-Process Quality Assurance (IPQA) Officer to join our Quality Assurance team. The IPQA Officer will be responsible for ensuring that all manufacturing processes adhere to Good Manufacturing Practices (GMP) and established quality standards. This role is critical in maintaining the integrity, safety, and efficacy of our pharmaceutical products by monitoring and verifying compliance throughout the production lifecycle.

Responsibilities:

· In-Process Monitoring: Conduct routine in-process checks and inspections across various manufacturing stages (e.g., dispensing, granulation, compression, coating, primary/secondary packing) to ensure compliance with Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs).

· Documentation Review: Review and verify all manufacturing documentation, including BMRs, logbooks, and in-process control records, for accuracy, completeness, and adherence to regulatory requirements.

· Sampling & Analysis Coordination: Oversee and verify in-process sampling activities and coordinate with the Quality Control (QC) laboratory for timely analysis of samples. Review QC results against specifications.

· Line Clearance & Set-Up Approval: Perform and approve line clearances before the start of manufacturing operations to prevent mix-ups and contamination.

· Deviation Management: Identify, investigate, and document any deviations, non-conformances, or discrepancies observed during in-process checks. Collaborate with production and other relevant departments to determine root causes and implement corrective and preventive actions (CAPAs).

· Environmental Monitoring Support: Support environmental monitoring activities in manufacturing areas as per established schedules and procedures.

· Compliance & Audit Readiness: Ensure continuous adherence to national and international GMP regulations (e.g., Indian Drugs & Cosmetics Act, US FDA, WHO GMP). Assist during internal and external audits and regulatory inspections.

· Continuous Improvement: Actively participate in continuous improvement initiatives related to quality systems and manufacturing processes.

Qualifications:

· Education: Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm)

· Experience: 2-5 years of experience in Quality Assurance or In-Process Quality Assurance within a pharmaceutical manufacturing plant.

Skills & Competencies:

· GMP Knowledge: Strong understanding of current Good Manufacturing Practices (cGMP), GLP, and relevant regulatory guidelines.

· Technical Skills: Familiarity with pharmaceutical manufacturing processes, equipment, and quality control tests.

· Analytical Skills: Excellent observational, analytical, and problem-solving skills with a keen eye for detail.

· Communication: Strong written and verbal communication skills. Ability to effectively interact with all levels of the organization.

· Computer Proficiency: Proficient in using Microsoft Office Suite (Word, Excel).

· Work Ethic: Highly organized, meticulous, proactive, and able to work independently as well as part of a team.

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Job Type: Full-time

Work Location: In person

Expected Start Date: 15/07/2025