Quality Assurance Human Resources

PAYAL PATEL

*** # **** –Martin Grove Road,

Etobicoke, Toronto, ON.

M9V 3T1

Home: 416-***-****,

Cell: 647-***-****

Email ID: *************@*****.***

Objectives: Seeking for the position in packaging in the medical field while merging into a globally focused organization that will purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.

Summary of Qualifications:

• Deep knowledge of cGMP and monitoring procedures.

• Detailed knowledge of GCP and ICH guidelines including basic understanding o regulatory requirements.

• Equipment parts that come in contact with raw materials, in-process drugs or drugs are accessible to cleaning or are removable.

• Equipment is located at a sufficient distance from other equipment and walls to permit cleaning of the equipment and adjacent area.

• Equipment is kept clean, dry, and protected from contamination when stored

• Working as per USFDA, ANVISA, EMEA, CDSCO guidelines and facing audits from the regulatory body.

• Comprehensive knowledge of Covance S.O.P.'s for site monitoring.

• Basic knowledge of manufacturing, packaging and clinical trial process.

Skills:

• Able to work under optimal supervision.

• Excellent organization, planning and problem solving abilities.

• Established interpersonal and communication skills.

• Fluent in English and other local office languages both verbal and written.

• Proficiency in computer.

• Able to work effectively and efficiently in a matrix environment.

• Effective at multitasking and working under pressure to accomplish overall objectives.

Core Competencies:

• Production and packaging

• Sterile injectibles

• Regulatory Issues

• Research and Development

• Client Relations Management

• Strategic and Tactical Planning

• Report Generation.

Technical Skills:

• Process/manufacture products in accordance with written processing orders.

• Prepare manufacturing areas and equipment for the production of pharmaceutical products.

• Clean processing equipment and rooms in accordance with written Standard Operating Procedures (SOPs) and established Good Manufacturing Practices.

• Effectively troubleshoot any equipment trained on.

• Provide feedback and process improvement suggestions.

• Ensure product quality meets the standards of Company, our clients and applicable regulatory agencies including, but not limited to: the Health Products and Food Branch Inspectorate (HPFBI), United States Food & Drug Administration (FDA), and European Medicines Agency (EMEA.nmental Health & Safety (EH&S) and Good Manufacturing Practices requirements.

• Other duties assigned.

Professional Experience:

Sun Pharmaceutical Industries Limited. October 2006 to May 2012

• Co-ordinate, assign and supervise all production activities and outcomes for area of responsibility to ensure production schedule/agreed upon goals and objectives are met.

• Preparation and Implementation of Standard operating procedure.

• Develop systems and metrics to measure and evaluate both productivity and individual performance and contribution on an on-going basis.

• Provide strong leadership to the team that fosters personal development, interaction and participation.

• Ensure department is professional and all work is performed in compliance with all regulatory requirements (GMP, safety) and company policies.

• Initiate investigations and provide or implement preventive/corrective action for all safety and compliance non-conformances.

• Provide recommendations to the next level of management regarding procedural and organizational changes.

• Responsible for the resolution of all employee issues within the department with the involvement of the next level of management and human resources as required.

• Prevents safety incidents / accidents proactively by attending regular safety events as required, and applying relevant knowledge to daily packaging operations

• Reports all safety incidents, near misses, and accidents immediately, following Safe Work Procedures (SWP’s)

• Executes Packaging Orders (PO) with efficiency and effectiveness according to the company SOD’s and regulatory requirements

• Operates all packaging equipment within specifications and provides accurate detail to mechanical staff regarding equipment problems

• Maintains proper supplies of packaging components during the operations

• Participates in the changeover process, including sanitation and set-up (assembly and disassembly), to meet and exceed established standards

• Ensures the proper selection, care and use of tools, parts and equipment required for specific tasks

• Communicates necessary information timely and accurately with others.

• Supports the team to deliver the expected business results with dedication and integrity.

• Carries out other duties as assigned.

• Exhibits Good Documentation Practices (GDP) Conducts quality checks as directed by higher level technicians, supervisors, and / or in-process Quality Assurance members (IPQA / QAIP)

Education:

2011: Master in Clinical Research and Regulatory affairs from Sikkim Manipal University (DE)

2006: Bachelor in Pharmacy from Sardar Patel University,

2007: GCP Certificate from Arkus clinical support solution.

Reference: Available upon request.

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