Website:
qvents.in
Job details:
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
- QA / IPQA Experience in Pharma API Industry
- Understanding of API Unit processes
- Expertise in cGMP requirements
Type of Experience : QA experience in Pharma API industry, regulated markets
Academic Qualifications
- Bachelor of Science (BSc)cGMP Regulations, Master Batch Records, Quality Documentation, Standard Operating Procedure (SOP)
Job Post Link : https://tinyurl.com/5fjkt7mn
- Full Time
- India | Telengana | Digwal
- Posted 22 hours ago
Website Linkedin
Piramal Pharma Solutions (PPS)
To apply for this job please visit piramalpharma.wd102.myworkdayjobs.com.
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