Executive - IPQA

Piramal Pharma Ltd; Kohir mandal; On-site; INR 450,000 - 650,000; Full time

Job summary

Piramal Critical Care, part of Piramal Pharma, seeks an Executive - IPQA to ensure GMP/cGMP compliance and robust quality document control across manufacturing and warehouse operations.

The role handles line clearance, BMR/BFR/BPR reviews, IPQA checks, APQR data, and collaboration with validation programs to uphold product quality.

Qualifications

• BSc degree or equivalent in science.
• Familiarity with cGMP and GMP regulations.
• Experience with batch records review and quality documentation.
• Understanding of APQR data collection and trend analysis.

Responsibilities

• Carry out IPQA activities including line clearance and in-process monitoring.
• Review BMR/BFR/BPR for completeness and compliance.
• Perform IPQA checks, shop floor surveillance, and SOP adherence.
• Manage control samples: collection, labeling, storage and retention.
• Collect in-process and finished product samples per approved plans.
• Compile APQR data and perform trend analyses for improvements.
• Participate in process and cleaning validation and related studies.
• Coordinate batch release activities and deviations closure.
• Conduct GMP and GDP inspections and initiate corrective actions.
• Coordinate vendor qualification and drive vendor approvals and evaluations.
• Maintain archival systems for quality documents and batch records.
• Issue, control and reconcile quality documents throughout their lifecycle.

Skills

IPQA

GMP compliance

QA documentation

Batch records review

Vendor qualification

Education

BSc

Tools

BMR/BFR/BPR

APQR data

SOPs

Job description

Division

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Executive - IPQA

Job Description

Responsible for carrying out IPQA activities, including line clearance, in-process quality monitoring, review of batch records (BMR/BFR/BPR), sample collection and control sample management, batch release coordination, and participation in validation studies. The role also includes routine GMP compliance verification across manufacturing and warehouse operations, APQR data compilation and trend analysis, vendor documentation review, document archival, and issuance and control of quality documents such as SOPs, specifications, formats, and batch records to ensure compliance with cGMP and regulatory requirements.

1. Perform line clearance for dispensing, manufacturing, filling, and packaging operations prior to batch commencement and product changeover to ensure compliance with cGMP requirements.

2. Review and verify Batch Manufacturing Records (BMR), Batch Filling Records (BFR), and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with approved procedures.

3. Carry out in-process Quality Assurance (IPQA) activities, including monitoring critical process parameters, in-process checks, shop floor surveillance, and ensuring adherence to approved SOPs and cGMP guidelines.

4. Manage control samples by ensuring proper collection, labeling, storage, retrieval, and retention in accordance with established procedures.

5. Collect and manage in-process, finished product, stability (where applicable), and customer samples as per approved sampling plans and SOPs.

6. Compile Annual Product Quality Review (APQR) data, perform trend analysis, and support the preparation of APQR reports to identify opportunities for continuous improvement.

7. Participate in process validation, cleaning validation (where applicable), hold time studies, media fill activities (for sterile facilities), and other qualification and validation programs.

8. Coordinate batch release activities by reviewing quality documentation, ensuring closure of deviations (where applicable), and facilitating timely disposition of finished products.

9. Conduct routine GMP and GDP compliance inspections across Production, Warehouse, Quality Control, Engineering, and other functional areas, and initiate corrective actions for any non-compliance observed.

10. Coordinate vendor qualification activities by reviewing vendor-related documentation, compiling vendor assessment reports, and supporting vendor approval and periodic evaluation processes.

11. Maintain document archival systems by ensuring secure storage, retrieval, and retention of quality documents in accordance with document retention policies and regulatory requirements.

12. Issue, control, reconcile, and maintain quality documents, including SOPs, specifications, formats, logbooks, and Batch Manufacturing/Packaging Records, ensuring effective document control throughout their lifecycle.

This version is suitable for inclusion in a formal HR Job Description and aligns with GMP expectations for regulated pharmaceutical manufacturing environments.

Bachelor of Science (BSc)cGMP Regulations, Master Batch Records, Quality Documentation, Standard Operating Procedure (SOP)