accwlh@r.postjobfree.com BOB DANISCH

408-***-**** Campbell, CA

SUMMARY

GMP experience in biotech, generic and solid dose drug products. Expertise in compliance and technical review of GMP regulatory records. Strengths include technical and GMP compliance review of QC data, batch records, methods, deviations, investigations, validation and transfer. Wrote and approved methods, validation protocols, reports, SOPs, manufacturing batch records and related GMP quality documentation. Test method and SOP gap analysis. Supported GMP manufacturing process documents, related QA support systems and lot disposition.

CORE COMPETENCIES/ KEY WORDS

GMP compliance of records, systems and related quality records; QC methods, validation and transfer protocols and reports, Lab controls and calibration, ICH Q2(R1), 21CFR211; ISO/IEC 17025, SOPs, batch record review, Trackwise, LIMS, Empower, SAP, QC deviations, investigations, OOS/ OOT, immunoassays, ELISA, GLP, GCP, ISO-9001 quality teams, QC APR data, CAPA, HPLC, CRO collaboration.

EXPERIENCE

Gilead Sciences, Foster City, CA.

Quality Contractor, Analytical Development and QC 10/2012 to 12/2013

- Reviewed QC stability analytical data for accuracy, integrity and compliance.

Verified QC stability data from HPLC Empower, Labware LIMS, and data sheets.

Identified gaps in test methods and SOPs.

Assessed deviations/ discrepancies for accuracy, completeness and compliance.

Provided a summary of review, discrepancies noted and recommended correction

Verified data for regulatory filings and audit response, stability LIMS reports.

Review included SOPs, test methods and respective compliance.

Verified compliance with applicable GMP/ company procedures and requirements.

TEVA Pharmaceuticals USA, Irvine, CA;

Quality Contractor, QC Remediation 6/ 2011 to 10/2012

Reviewed COA data for commercial lot release of generic drugs API, Bulk, FP

Assessed QC GMP data, deviations for compliance and technical content using cGMP practices, sound judgment and company standards.

Verified compliance of QC data for HPLC, GC and MS, USP methods, for purity, assay, residual solvents, impurities and degradation products.

Reviewed and assessed GMP documents including SOPs, test methods for compliance to internal standards, validation, QC investigations, microbial limits.

Wrote and reviewed method validation and transfer protocols and reports, including CRO sites, to ensure quality compliance to relevant procedures.

Collaborated and provided feedback to contract testing labs: QC test data, deviations, validation and transfer studies, and associated GMP records.

GENENTECH Inc, South San Francisco, CA;

QC Manager 1996- 2011

- Batch record review/approval of COA data for commercial lot release.

Supported investigations of commercial product.

Supported lot disposition, release timelines.

Assessed and approved OOS/ OOT investigations, QC deviations.

Wrote and reviewed QC method validation protocols and reports.

Reviewed manufacturing batch records, supported deviation, investigations.

Provided APR reports of QC data for commercial products

Established a QC metrics system to monitor and trend QC work.

Conducted technical training on GMP compliance and QC methodology.

Collaborated with QA/ RA to meet inventory needs, GMP audit commitments and regulatory submissions.

Supported QC/QA systems: LIMS, product complaints, CAPA, SAP, Trackwise.

Led the re-design of group roles, responsibilities and data review process.

Exercised compliance/ mature judgment on QC project teams and daily work assignments

Wrote procedures (methods, SOPs) and protocols to describe and qualify test methods and instruments.?

Provided support for manufacturing and process development.

Collaborated to improve the reliability of analytical methods and ensure compliance with applicable quality standards and guidelines.

Collaborated with CROs for clinical trial data collection using Medidata Rave

Supported the clinical trial study team, managed CRO lab data, discrepancies.

Clinical Trial Team/ Data Manager: Audited clinical trial lab data for integrity, accuracy and compliance to protocol; collaborated with CROs for data collection, e-transfer, user acceptance testing, scope of work; supported the setup of the data collection database (Medidata Rave).

Laboratory Expertise

HPLC theory, practice, method validation, system suitability and troubleshooting.

ELISA/ immunoassay development and process transfer.

Enzyme conjugation/ antibody purification using HPLC methodology.

Lab equipment IQ/OQ/PQ, log records

Wrote and performed method validation protocols using ICH guidelines, Q2(R1).

EDUCATION/ TRAINING/ LICENSE:

M. S. Medical Technology: C.W. Post College, Greenvale,N.Y.

B. S. Medical Technology: Quinnipiac College, Hamden, Conn.

San Jose State University certificate programs:

ISO 9000, Quality Systems

Project Management

- California Clinical Laboratory Scientist, license no MTA 19923

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