Manage CMOs/Vendors, Batch Review Release/Disposition, Manage Deviations, CAPAs, Change Controls, OOS; Review Release Testing Raw Data, Stability Testing, QC Method Validation, QC Method Transfer, Risk Assessment, Validation, Technical Review of IND & NDA, SOPs, Training, Temperature Excursion Assessment, Quality Metrics, Specifications approvals, Quality Agreement.

Manage CMOs/Vendors, Batch Review Release/Disposition, Manage Deviations, CAPAs, Change Controls, OOS; Review Release Testing Raw Data, Stability Testing, QC Method Validation, QC Method Transfer, Risk Assessment, Validation, Technical Review of IND & NDA, SOPs, Training, Temperature Excursion Assessment, Quality Metrics, Specifications approvals, Quality Agreement.

Aseptic Manufacturing

• Review & approval of pre-executed and post-executed batch records for clinical, developmental, and R&D batches for drug substance, drug product, packaging and labeling operations for solid dosage and parenteral/sterile per the pertinent timelines.• Ensured the labelling batches complied with CMC information pertinent to IND, NDA and IMPD filings for the USA and European Union, Switzerland, Latin America, and Canada and as applicable.• Manages the review/release of the batch records and ensures timely release of the products.• Prepares score card metrics and presents to the quality management.• Authors investigation(s) and identifies root causes and assigns CAPAs as applicable.• Qualifies Vendors/CMOs/CSPs for reduced batch record review.• Performs assessment(s) on temperature excursions of supplies in transit and at Vendor/CMO/CSP sites, clinical sites & depots.• Applies risk management principles to quality reviews of deviations and batch records• Authors/reviews SOPs, work practices and training documents.• Collaborates/negotiates with CMOs and ensures cGMPs and Celgene quality requirements in the review and release of batches.• Leads batch disposition meeting(s) and ensures batches are released in a timely fashion to meet business needs.• Supports senior management in value added projects such as temperature excursion management initiative, risk management Initiative, use by date extension project, streamline of the batch record review process by improving efficiency, systematic organization of the resources and appropriate resource allocation, acted as a QA representative in the good distribution practice meetings.• Active role in QA support for biologics pilot plant/kilo lab. The activities include commissioning/qualification.• Represents quality in the cross functional team meetings and provides updates and inputs to the biologic pilot plant activities.

• Effectively managed quality inspector’s team on day-to-day activities such as In-process inspection, batch record reviews, training activities etc.• Monitored bottle and blister packaging lines, liquid filling lines, tube filling lines, manufacturing operations (dispensing, compaction) for suppositories, liquids, and semi-solids.• Reviewed parenteral/solid dosage/liquid dosage batch records.• Hands on experience in milling, blending, and compaction equipments.• Performed batch record review/release, and ensured that records met quality and cGMP requirements.• Worked with validation department on proper execution of validation batches and cleaning validation protocols.• Authored and revised SOP protocols, and rework procedures as necessary.• Authored deviations and investigations as necessary. Ensured that the assigned CAPAs are completed on time in the area of responsibility.

Quality Oversight of manufacturing and packaging operations at the CMO sites.Ensured the Contractor Manufacturers/packagers meet the quality requirements.Acted as a person in plant and ensured the manufacturing and packaging processes ran in compliance and met product launch timelines.

• Managed Quality Assurance personnel performing quality functions in manufacturing and packaging operations• Effectively monitored and managed bottle/blister packaging lines, liquid filling lines, manufacturing operations such as dispensing, granulation, compression, encapsulation and coating for Solid dosage and Liquid dosage.• Experience with compression equipment, blenders, coating equipment, bottle packaging equipment and liquid filling equipment, fluidized bed mixer etc.• Performed GMP internal annual and routine audits.• Performed Packaging and Manufacturing line clearance checks and verified calibration and monitored RO water systems. • Reviewed Parenteral/Solid Dosage/Liquid Dosage Batch Records.• Ensured validation, stability and submission batches meet batch record requirements.• Worked on Process Optimization, Scale-Up, R&D, and experimental batches.• Monitored the execution of IQ, OQ, and PQ.• Performed inventory management on control substances and extensively monitored daily transactions of control substance cage.• Authored Investigations, Deviations, and CAPAs and implemented change controls and trained personnel accordingly.• Responsible for employee performance evaluations, new employee hiring.

• Performed QC Lab tests, for assay, content uniformity, water activity, moisture content, sensory analysis. • Audited QC, manufacturing and packaging operations logbooks.• Placed indents for all the Chemicals and Lab utilities. Maintained control samples and Audited Batch Records.