Executive – IPQA

Qvents.In

Kolkata Metropolitan Area

On-site

INR 420,000 - 620,000

Full time

2 hours ago

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Job summary

Piramal Pharma Solutions (PPS) is seeking an Executive in Quality Assurance (IPQA) to perform line clearance, in-process quality monitoring, and batch record review. The role includes sample management, APQR data compilation, and participation in validation programs to ensure cGMP compliance across sites.

The candidate will coordinate batch release, manage control samples, and contribute to document archiving and control of SOPs and specifications in a fast-paced manufacturing environment.

Qualifications

QA / IPQA experience in pharma API industry.
Understanding of API unit processes.
Expertise in cGMP requirements.

Responsibilities

Perform IPQA activities including line clearance, in-process monitoring, and batch review.
Coordinate batch release activities and ensure deviations are closed.
Review BMR/BFR/BPR for accuracy and compliance with procedures.
Manage control samples and sampling plans per SOPs.
Support APQR data compilation, trend analysis, and report preparation.
Conduct GMP/GDP compliance inspections across production, warehouse, and QA functions.

Skills

QA / IPQA experience

API unit processes

cGMP requirements

Education

Bachelor of Science (BSc)

Job description

Designation : Executive

Function : Quality Assurance

Functional Area : IPQA

Job Role Summary : 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.

Job Profile

Perform line clearance for dispensing, manufacturing, filling, and packaging operations prior to batch commencement and product changeover to ensure compliance with cGMP requirements.
Review and verify Batch Manufacturing Records (BMR), Batch Filling Records (BFR), and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with approved procedures.
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.
Manage control samples by ensuring proper collection, labeling, storage, retrieval, and retention in accordance with established procedures.
Collect and manage in-process, finished product, stability (where applicable), and customer samples as per approved sampling plans and SOPs.
Compile Annual Product Quality Review (APQR) data, perform trend analysis, and support the preparation of APQR reports to identify opportunities for continuous improvement.
Participate in process validation, cleaning validation (where applicable), hold time studies, media fill activities (for sterile facilities), and other qualification and validation programs.
Coordinate batch release activities by reviewing quality documentation, ensuring closure of deviations (where applicable), and facilitating timely disposition of finished products.
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.
Coordinate vendor qualification activities by reviewing vendor-related documentation, compiling vendor assessment reports, and supporting vendor approval and periodic evaluation processes.
Maintain document archival systems by ensuring secure storage, retrieval, and retention of quality documents in accordance with document retention policies and regulatory requirements.
Issue, control, reconcile, and maintain quality documents, including SOPs, specifications, formats, logbooks, and Batch Manufacturing/Packaging Records, ensuring effective document control throughout their lifecycle.

Job Requirements