Director/Manager of Quality Assurance

SAVITA MEHRA

Phone: 302-***-**** E-mail: *********@*****.***

PROFESSIONAL SUMMARY

Extensive experience in developing, implementing and successfully sustaining quality management systems in various industries, including manufacturing and virtual pharmaceutical facilities, assuring compliance to local and international requirements. Proven expertise in developing quality improvement plans, supplier management program, auditing, streamlining procedures/processes, handling customer complaints and verifying effectiveness of CAPAs. Strengths include interpretation of standards/regulations, negotiating contracts, providing regulatory guidance, inspection readiness, mentoring staff, harmoniously interfacing with cross functional teams while focusing on product quality and patient/recipient safety. Certified Lead Assessor for ISO 13485. Proficient in:

QMS Implementation, Project Management, Quality Risk Management

Vendor/Supplier Management, Process Mapping, Quality Metrics

GxP audits and Training

EXPERIENCE

Shire Pharmaceuticals, Exton, PA (acquired ViroPharma) Jan. 2014 – Dec. 2016

GQA, GMP Manager/Audit Lead

Supported QMS, internal and supplier audit program for small molecule, biologics and ancillary Medical Devices for commercial and clinical/developmental products. Performed GMP, GCP, GLP and GDP audits based on 21 CFR Part 11, 210,211,600,640,820, ISO13485, ISO 14971, ISO9001, ICH, DEA, MCA, MHRA, GHA, EU directives and US Pharmacopeia, qualifying CRO’s, CMO’s, source plasma centers, contracted labs., API and sterile product manufacturers, raw material and packaging suppliers, specialty pharmacies and nursing network and 3PL service providers. Maintained strong relations with suppliers. Managed change control, validation, CAPA, product complaints and risk assessment program.

Hosted regulatory and customer audits, championed process improvement activities, streamlined SOP’s and trained employees. Nominated for CEO’s Excellence Award in 2015 and recognized for “going above and beyond” in 2016. Mentored employees.

ViroPharma Inc, Exton, PA April, 2012 – April, 2014

QA/GMP Audit Manager

Supported QMS and global internal and external audit programs, based on 21 CFR Part 11, 210,211,600,640,820, ISO13485, ISO 14971, ISO9001, ICHQ7, ICHQ9, ICHQ10, DEA, MCA, MHRA, GHA, EU directives and US Pharmacopeia. Managed supplier qualification in US, Canada, Europe and Latin America, supporting commercial and clinical/development products (small molecule, biologics and Ancillary Medical Devices). Trained employees on regulatory requirements..

Developed supplier risk assessment program, authored SOPs, developed QTA’s. Managed 3rd party auditors. Developed work flows for software application (TrackWise).

Sodexo Inc. (contractor at GlaxoSmithKline), Upper Merion, PA Nov. 2011- April 2012

Director of Quality and Compliance - US region

Responsible for Quality Management System at all locations within USA, assured compliance to cGMPs, 21 CFR Part 11, 210 and 211.

Overseeing change control, document control, deviations, root causes analysis, CAPA Internal/External audits and employee training program. Performed risk assessment on operations related to Consumer Health Products. Streamlined quality metrics and SPC data tracking, presented reports to GSK’s Quality Committee and Regional Board.

Blood Bank of Delmarva, Newark, DE. (Manufacturing Site) August 2005-May 2011

Director of QA/Compliance and Regulatory Affairs

Managed QMS, assured compliance to 21 CFR Part 11, 210, 211, 600 and 640 for multiple sites (DE, MD and VA). Liaison for regulatory agencies (FDA, STATE/CLIA, AABB, EU and customers). Regulatory submissions to the FDA along with the annual reports and BPDR’s, in addition maintained establishment licenses. Conducted GMP training. Championed process improvement initiatives, facilitated Kaizen events. Authored QA manual and Disaster Recovery Plan. Developed KPI’s, mentored staff and developed strategic goals.

Global Secure Safety, Bear, DE. July 2002- August 2005

Director of Quality Assurance

Overseeing QA/QC activities in manufacturing, assuring compliance to IS0 9001, NIOSH, and NFPA requirements. Achieved ISO 9001 certification in 8 months. Interacted with all the support groups, actively participated in design control activities. Developed FMEAs, prepared process/product validation plans, implemented vendor rating and SPC program, Trained internal auditors, developed organization wide KPIs.

ADDITIONAL RELEVANT EXPERIENCE

Lear Corp, New Castle, DE (Mfg.) Title: Quality Assurance Manager

Flair-New Castle, Inc., New Castle, DE (Mfg.) Title: Quality Assurance Manager

Cairns Air Inc., Bear, DE (Mfg.) Title: Quality Assurance Manager

Alloy Surfaces Company, Inc. Wilm. DE. (Mfg.) Title: Quality Assurance Manager

TRAINING AND EDUCATION

Data Integrity, Software validation, ISO9001, PPTA annual forums, Lead Assessor Certification (ISO 13845), IQPP International forum, Risk Assessment, ISO 14971, Process mapping, Project management, Lean manufacturing, FDA workshop (electronic submission of BLA, and Inspection Readiness), FDA workshops and Pharma Conferences. AABB conferences. Six Sigma, Malcolm Baldridge Quality Award Evaluation, Six Sigma, 5S, QS9000, Bench Marking, TQM and SPC training. ASQ Member.

Cont. Education at University of Delaware, Basic, Pascal and C-Basic language and Liberal Arts courses.

Completed 1 year towards M.Sc. in Biology.

B.Sc. (Chemistry and Biology).

Pre-Med Degree.

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