Core Competences and Strengths in Pharmaceutical Quality
1. CORE COMPETENCES AND STRENGTHS
DALIP S. GILL, PhD,
dalipgill@hotmail.com Tel: 732-735-4132
1 Knowledge, and practice of cGMPs, GLPs, and Good Documentation
Practices (Certified Pharmaceutical GMP Professional: ASQ).
2 Subject Matter expertise in Quality Auditing for GMP & ISO standards
(Certified Quality Auditor: ASQ)
3 Write, Review, and Approve pharmaceutical technical documents,
laboratory controls & records, and production batch controls & records to
support product and process development, release of commercial
products, and support CMC sections of regulatory filings.
4 In depth working knowledge of Laboratory operations of method
development, method validation, and analytical cGMP testing of
pharmaceutical materials [Raw materials, Process Intermediates, Drug
Substance, and Drug Product] .
5 Stability testing to support Pharmaceutical Product Development, writing
Stability Protocols, analyzing data, and writing Stability Reports.
6 Implement, execute, and sustain elements of Pharmaceutical Quality
System (change control, audits, deviations, investigations, root cause
analysis, CAPA).
7 Solid scientific background in Biochemistry, Chemistry, Molecular
Biology, Cell Biology, and Virology (List of Publications).
8 Current with knowledge of relevant ICH, EU, and FDA guidance
documents, CFR 21, Parts 210, 211, 58, 11, & 820, Microsoft Office,
Statistics, and LIMS.
9 Hands-on as well as executive level 25 years solid experience of working in
regulated major pharmaceutical and biotechnology companies with branded
and un-branded biologics and health care pharmaceutical products.
DALIP S. GILL, PhD, CPGP: ASQ, and CQA:ASQ
![CORE COMPETENCES AND STRENGTHS
DALIP S. GILL, PhD,
dalipgill@hotmail.com Tel: 732-735-4132
1 Knowledge, and practice of cGMPs, GLPs, and Good Documentation
Practices (Certified Pharmaceutical GMP Professional: ASQ).
2 Subject Matter expertise in Quality Auditing for GMP & ISO standards
(Certified Quality Auditor: ASQ)
3 Write, Review, and Approve pharmaceutical technical documents,
laboratory controls & records, and production batch controls & records to
support product and process development, release of commercial
products, and support CMC sections of regulatory filings.
4 In depth working knowledge of Laboratory operations of method
development, method validation, and analytical cGMP testing of
pharmaceutical materials [Raw materials, Process Intermediates, Drug
Substance, and Drug Product] .
5 Stability testing to support Pharmaceutical Product Development, writing
Stability Protocols, analyzing data, and writing Stability Reports.
6 Implement, execute, and sustain elements of Pharmaceutical Quality
System (change control, audits, deviations, investigations, root cause
analysis, CAPA).
7 Solid scientific background in Biochemistry, Chemistry, Molecular
Biology, Cell Biology, and Virology (List of Publications).
8 Current with knowledge of relevant ICH, EU, and FDA guidance
documents, CFR 21, Parts 210, 211, 58, 11, & 820, Microsoft Office,
Statistics, and LIMS.
9 Hands-on as well as executive level 25 years solid experience of working in
regulated major pharmaceutical and biotechnology companies with branded
and un-branded biologics and health care pharmaceutical products.
DALIP S. GILL, PhD, CPGP: ASQ, and CQA:ASQ](https://image.slidesharecdn.com/36960164-4ece-477d-b51e-8ae89846c43f-160701034431/85/core-competences-and-strengths-1-320.jpg)
