Senior Quality Specialist, Customer Quality & Data Integrity

Be the First to Apply Division Piramal  Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.comJob Title Senior Quality Specialist, Customer Quality & Data Integrity

Job Description The Senior Quality Specialist, Customer Quality & Data Integrity is an experienced Quality individual contributor responsible for independent review of analytical and microbiological laboratory data and for completion of assigned Quality Assurance deliverables supporting batch disposition, customer programs, and project execution in a cGMP pharmaceutical environment. The role provides day-to-day execution support to the Senior Quality Assurance, Customer & Project Lead team by ensuring that QC laboratory records, investigations, change controls, and supporting documentation are complete, accurate, scientifically sound, traceable, and ready for Quality approval and customer commitments.

The position builds on the technical foundation of a Senior QC Analyst while shifting primary accountability from routine testing to Quality review, documentation assessment, issue follow-up, and timely closure of assigned deliverables. The reviewer applies independent Quality judgment within approved procedures, maintains separation from work personally performed when required, and escalates significant product, patient, compliance, data-integrity, customer, or schedule risks to management.

Regulatory and corporate requirements:
Adhere to applicable FDA requirements, 21 CFR Parts 210, 211, and 11 as applicable, EU GMP, USP/EP requirements, ICH guidance, approved site procedures, and corporate Quality, safety, health, and environmental policies.

Values:
Demonstrate integrity, scientific rigor, transparency, ownership, respectful challenge, customer focus, and Piramal Pharma Solutions standards of ethical conduct.

KEY

ACCOUNTABILITIES QC Laboratory Data Review:
Perform independent review of analytical chemistry and microbiology records supporting raw materials, in-process materials, finished products, stability samples, cleaning verification/validation, methods, transfers, validations, and investigations. Verify completeness, accuracy, legibility, traceability, procedural compliance, and consistency across source records and reported results.

Analytical Data Review:
Review worksheets, notebooks, instrument outputs, chromatograms, calculations, dilution factors, standards, reagents, sample preparations, system suitability, sequences, integration, processing parameters, specifications, LIMS entries, certificates, protocols, and reports. Confirm that reported results are supported by complete and scientifically valid source data.

Microbiology Data Review:
Review microbiology testing and associated records, including sample identification, media and reagent controls, incubation conditions, growth promotion and suitability requirements, colony counts or observations, calculations, environmental or utility monitoring data as assigned, method requirements, specifications, LIMS entries, and final reporting. Obtain qualified microbiology subject-matter support when interpretation exceeds the reviewer’s qualification.

Electronic Data and Data Integrity:
Review applicable electronic records, metadata, audit trails, sequence activity, reprocessing, reintegration, repeat testing, aborted runs, manual entries, user actions, date/time information, and unexplained or unreported data in accordance with approved procedures. Apply ALCOA+ principles and promptly escalate potential data-integrity concerns.

QA Batch Record and Disposition Support:
Complete the QC laboratory-data portion of QA batch-record review. Confirm that required testing is complete, results meet approved specifications,…