Dev PalMs Email & Phone Number | 20+ years of focused leadership in Life Sciences domain for SAP/Oracle ERP SCM, Veeva Vault Quality Systems, CSV->CSA transition, Data Integrity, Validation, Clinical, EDC, Technical Writing roles within the Pharmaceutical, Bio-manufacturing, Cell & Gene Therapy. Functional experience in configuring SCM/Inventory, PLM and Quality Management modules. Test Lead for multiple large scale global projects across ERP spectrum. Proficient with Quality Systems workflows for Quality Events- Change Controls, Product Complaints, Deviations, Investigations, CAPAs, CAPA Action items, Lab Investigations, OOS/OOT, , Effectiveness Checks, Supplier and Internal Audits, Supplier Assessments, Veeva Certified. Highly adept and experienced in creating, executing and reviewing Validation & Testing deliverables for new and remediated GxP systems. Hands-on experience includes Validation of Rave/NESS EDC; SAP/Oracle ERP, Veeva eQMS, Quality Docs, RIMS, eTMF, Mastercontrol, Empower, Labware/Labvantage LIMS, Nugenesis, Werum/Syncade MES and Serialization. Precise working knowledge of Regulated Data Integrity best practices and Computer Systems Validation (URS, FS, VMP, Test Scripts, TM, VSR, SOPs) Facilities, Equipment, Utilities Validation for Aseptic manufacturing and Solid dosage products. Excellent written and verbal communication skills with ability to effectively influence in a team environment. US Citizen.

Dev PalMs

20+ years of focused leadership in Life Sciences domain for SAP/Oracle ERP SCM, Veeva Vault Quality...
United States

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Dev PalMs’s Email dpal@karunatx.com

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Dev PalMs’s Location United States

Dev PalMs’s Current Industry Wave Life Sciences

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Work Experience

Wave Life Sciences

Sr. Consultant

2023-07-01 00:00:00 - Present

Sarepta Therapeutics

eQMS SME Lead Consultant

2022-07-01 00:00:00 - 2023-07-01 00:00:00

Karuna Therapeutics

Associate Director- GxP Computer Systems

2022-08-01 00:00:00 - 2022-12-01 00:00:00

Pii

Sr. Manager- Quality and Regulated Systems

2021-06-01 00:00:00 - 2022-07-01 00:00:00

Vertex Pharmaceuticals

Sr. Cell and Gene Therapy Consultant (SQA)

2021-03-01 00:00:00 - 2021-05-01 00:00:00

Moderna

Principal Consultant (Clarkston)

2019-08-01 00:00:00 - 2021-02-01 00:00:00

Psc Biotech

Regional Manager

2017-09-01 00:00:00 - 2019-07-01 00:00:00

Zimmer Biomet

Post Market Surveillance Consultant

2017-04-01 00:00:00 - 2017-08-01 00:00:00

The Clorox

Solution Architect- System of Records

2015-09-01 00:00:00 - 2017-03-01 00:00:00

Intuitive Surgical

Manager, IT Validation

2014-08-01 00:00:00 - 2015-08-01 00:00:00

Baxter International

Program Lead- Serialization (Wipro)

2013-03-01 00:00:00 - 2014-08-01 00:00:00

Takeda

QMS Manager-Consultant (Randstad)

2012-11-01 00:00:00 - 2013-02-01 00:00:00

Ge Healthcare

Manager, IT Validation

2011-06-01 00:00:00 - 2012-10-01 00:00:00

Forest Labs

Lead QA Specialist/Project Manager

2005-08-01 00:00:00 - 2011-06-01 00:00:00

Pfizer

Consultant (Washington Group Intl.)

2005-05-01 00:00:00 - 2005-08-01 00:00:00

Allergan

Sr. Validation Engineer (Watson Labs.)

2003-08-01 00:00:00 - 2005-05-01 00:00:00

Parexel

Senior Analyst (Wyeth Biopharma)

2002-09-01 00:00:00 - 2003-08-01 00:00:00

Skills

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Languages

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FAQ About Dev PalMs

Dev PalMs is located at
United States

Dev PalMs is a 20+ years of focused leadership in Life Sciences domain for SAP/Oracle ERP SCM, Veeva Vault Quality Systems, CSV->CSA transition, Data Integrity, Validation, Clinical, EDC, Technical Writing roles within the Pharmaceutical, Bio-manufacturing, Cell & Gene Therapy. Functional experience in configuring SCM/Inventory, PLM and Quality Management modules. Test Lead for multiple large scale global projects across ERP spectrum. Proficient with Quality Systems workflows for Quality Events- Change Controls, Product Complaints, Deviations, Investigations, CAPAs, CAPA Action items, Lab Investigations, OOS/OOT, , Effectiveness Checks, Supplier and Internal Audits, Supplier Assessments, Veeva Certified. Highly adept and experienced in creating, executing and reviewing Validation & Testing deliverables for new and remediated GxP systems. Hands-on experience includes Validation of Rave/NESS EDC; SAP/Oracle ERP, Veeva eQMS, Quality Docs, RIMS, eTMF, Mastercontrol, Empower, Labware/Labvantage LIMS, Nugenesis, Werum/Syncade MES and Serialization. Precise working knowledge of Regulated Data Integrity best practices and Computer Systems Validation (URS, FS, VMP, Test Scripts, TM, VSR, SOPs) Facilities, Equipment, Utilities Validation for Aseptic manufacturing and Solid dosage products. Excellent written and verbal communication skills with ability to effectively influence in a team environment. US Citizen.

Dev PalMs currently works in the Wave Life Sciences |

No Languages Available

Dev PalMs has prior
experience in the following industries:
Sarepta Therapeutics | Karuna Therapeutics | Pii | Vertex Pharmaceuticals | Moderna | Psc Biotech | Zimmer Biomet | The Clorox | Intuitive Surgical | Baxter International | Takeda | Ge Healthcare | Forest Labs | Pfizer | Allergan | Parexel

Dev PalMs has the following professional experience:
Wave Life Sciences | Sarepta Therapeutics | Karuna Therapeutics | Pii | Vertex Pharmaceuticals | Moderna | Psc Biotech | Zimmer Biomet | The Clorox | Intuitive Surgical | Baxter International | Takeda | Ge Healthcare | Forest Labs | Pfizer | Allergan | Parexel