SUMMARY

• Pharmaceutical industry/Medical device quality professional skilled in developing and managing strategic opportunities in Quality Assurance. Highly effective in representing Quality Assurance in a GMP driven team environment.
• Working noledge of Experience includes 21 CFR Part 211, 11, ICH guidelines, ISO 9001, and 13485 . Strong presentation, communication, interpersonal, and problem - solving skills. Exceptional training and people management skills.
• Solid experience in Quality Systems,, electronic document management (EDMS) system, and Quality Assurance related to manufacturing and packaging environments.
• Excellent project planning, execution, and promoting innovative solutions. Direct multiple projects and personnel to ensure daily workstreams and on time project deliverables.

TECHNICAL SKILLS

• Oracle, TrackWise Systems Database, EDMS systems (Master Control, QUMAS, Documentum)
• LMS (Compliance Wire) SharePoint, Adobe Professional, MS Excel, MS Word, MS PowerPoint, MS Outlook, Dropbox

PROFESSIONAL EXPERIENCE

Quality assurance Manager

Confidential

Responsibilities:

• Document Control and Quality Management Activities, including Implement New EDMS & LMS
• Implementing QMS System Compliant with ISO 13485, 21 CFR Part 211 (cGMPs), MDD.
• Create Training curriculum development for departments
• GMP and Systems trainings
• Author Quality Documentation including ISO Compliant SOPs/Forms/Work Instructions
• Participate in Stage 1& 2 Clinical Trial Activities for Duo Pharma/Med Device
• Participate in Quality Review and Project Meetings
• Conduct Management Review Meetings
• Certified Lead Auditor - Internal and External

ASSOCIATE manager

Confidential

Responsibilities:

• Led teh document control team in records management of SOPs, training documents (SOP, OJT, Seminars), master batch records, lab methods and specifications.
• Ensured that design flow processing, reviews, approvals, and EDMS complied with cGMPs.
• Managed compliance matrix by creating monthly KPI and quality metrics.
• Business owner of teh EDMS, LMS, and change management system.
• Quality documentation SME lead for system upgrades and leader of process improvement teams for current systems.
• Monitored distribution of periodic review notices and plant reports
• Participated in FDA/EMA and vendor inspections
• Key Quality SME for cross-functional process improvement/project teams
• 6S team member, conducting monthly audits of rotating manufacturing areas
• Review/Approve IQ/OQ/PQ documentation for quality systems, along with execution where appropriate
• Participate in Quality Council meetings and review of trending OOS items
• Conducted and documented deviation investigations according to established procedures
• Attended ongoing Coaching/Mentor trainings
• Managed process to transfer copies of 800 intra-site procedures during transition from TEVA to G&W ownership.
• Addressed issues of technical compliance in teh retention of original documents at teh TEVA site and migration of copies.
• On-boarded 70,000 documents from legacy company EDMS to new company system by directing project team including SMEs for targeted document types for teh new system.
• Develop/Perform GMP training for plant
• Worked cross functionally with vendors and IT project management to design an environment for end customers.
• Led team in creating business process model to meet teh needs and completely new methodologies of teh target EDMS.
• Maintained High Morale and Open Communication for my team during transitional period to new management.
• Document control liaison for implementation of learning management tool enabling communication between teh LMS and EDMS.
• Contributed to process design to correlate change in document lifecycle status in teh EDMS.

ASSOCIATE manager

Confidential

Responsibilities:

• Directed teh document control team in records management of SOPs, work instructions, training records, forms, master plans for corporate, and site documents.
• Ensured a 21 CFR Part 11 compliant EDMS by complete adherence to cGMPs for design flow processing, reviews, and approvals.
• Monitored distribution of periodic review notices.
• Accounted for teh EDMS, change management system end user training for key users and viewers on teh EDMS.
• Assisted with LMS (Learning Management System).
• Maintained High Morale and Open Communication for teams during period my facility was on a Corporate sunset plan.
• Managed eight-member process improvement team on an on-going basis.
• Contributing team member for implementing teh EDMS system for five sites running on a hard copy manual distribution system.
• Met with focus groups to design a methodology and process for end users.
• Organized resources needed and developed required training for teh EDMS rollout.
• Created an automated system to replace a manual system for lot number application, saving substantial time in issuing batch records.
• Brought organization and efficiency by developing a single tracking database source enabling queries and record distribution, resulting in recognition award for resourcefulness for critical deliverables for teh company.
• Conducted GMP training.