Quality Manager (Pharma) - Resume Example & Template

Resume of Quality Manager (Pharma) in Text Format

TANYA PRASAD

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QUALITY MANAGER - leveraging 12+ years of experience

Quality assurance executive with an industry experience of more than 12 years. Expert of national and international Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) regulations, guidance documents, and industry best practices. Methodical auditing skills with efficient risk identification methods. Well-ordered communication skills for coherently delivery of observations to both internal and external business partners and assisting in rectifying them.

PROFILE SUMMARY

• Designated ISO 13485 Management Representative ensures pertinent regulatory and customer requirements through the development, implementation, and refinement of quality plans and systems.
• Ability to effectively build and maintain relationships with multiple departments and external entities including Investigator sites, clinical Vendors and CROs in order to effectively solve problems.
• Proficiency in performing routine inspections and quality tests.
• Acquainted with the quality management cycle (i.e., PDCA), and corrective Action/Prevention Action (CAPA) processes.

CORE COMPETENCIES

• Quality Driven Management (QDM)
• Pharmaceutical Compliance
• Project Management
• Good Laboratory Practice
• Internal Auditing
• Good Manufacturing Practice (GMP)
• Product Lifecycle Management (PLM)
• Continuous Improvement Process (CIP)
• CAPA Quality Control
• Reporting and Documentation
• Quality Risk Assessment

PROFESSIONAL EXPERIENCE

Biotech Pharma, New Delhi Jan. 2017 – Present

Senior Director of Quality Management

• Lead and directs all quality assurance activities for the company.
• Oversee procedures for medical coding, internal data validation audits, clinical form development, and data and outcomes management for all contract programs.
• Administer Investigation and Deviation systems for tracking statuses, follow-up, and liaison with the applicable department, patient complaint management, IR/SE management and audit procedures to ensure timely resolution.
• Compile reports and identify trends or areas requiring additional actions.
• Develop strategic plans and policies for improved quality throughout the company and works with top management to ensure compliance with regulatory agencies. Support the activation of commercial sites and will perform quality risk assessments.
• Assist with completion of quality agreements; provide operational support for commercial site selection and activation of research and development laboratory centers.
• Manage interface with Quality Compliance audit team to support audit, due diligence, and inspection readiness plans.
• Administer internal audits and provides support for external inspections.
• Develop new and improved processes in collaboration with other QMS element Stewards and global leadership
• Provides quality systems support for all products including electromechanical, biomedical and medicines.
• Coordinate with plants, R&D, RA, and Labeling and other internal supervisors, functional peer and senior leaders and lead interactions with regulators and customers to represent the company products and processes.
• Identify and direct continuous improvement projects to achieve quality, reliability, and cost improvements.

Sun Pharmaceutical Industries Ltd., New Delhi | July. 2013 – Nov. 2016

Quality Manager

• Identified and drove continuous improvements to the product lifecycle management system while building and managing relationships with the National Business Units including R&D, regional supply chain, supplier quality management, post-market surveillance, marketing, and regulatory affairs to ensure alignment on strategic initiatives.
• Built new processes from scratch for production hurdles. Fostered trust within the team and helped create a better product for the customers.
• Served as one of the senior technical representatives in Product Development and Lifecycle Management (PDLM) in the Quality organization with responsibility for process results in terms of product quality, performance, and safety.
• Provided support for internal audits and external inspections.
• Developed new and improved processes in collaboration with other QMS element Stewards and global leadership. Influenced the decision-making process to ensure quality requirements.
• Includes all lifecycle phases from late-stage feasibility through development, sustaining, and discontinuation Served as the data architect for implementation of Product Lifecycle Management (PLM).
• Oversaw continuous improvement initiatives and actively complied with the company’s regulations.
• Participated as part of the Corporate Audit Team in both supplier and customer, regulatory, and internal audits.
• Provided quality and validation oversight including all facets of validation and development of quality control plan
• Reviewed designs and design changes, protocols, and document change requests.

Cipla Ltd., New Delhi | July. 2011 – Jun. 2013

Quality Manager

• Supported the development, implementation, maintenance, and oversight of a clinical quality management system.
• Facilitated working groups to collaborate and write project-controlled documents as part of the quality management system: SOPs, Policies and Audit reports.
• Supported the development and implementation of the Clinical Quality Management System (Master Control).
• Stayed abreast with current GCP/GCLP regulations, including FDA, EU, and other regulatory bodies.
• Led audits of the various quality elements to ensure compliance to GCP/GCLP, industry best practices and guidance.
• Participated in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management.
• Supported the development and reviewed GCP/GCLP audit agendas, audit plans, audit reports, and CAPA's.
• Participated in preparations for regulatory inspections, including reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
• Review, track, and/or trends routine quality data Reported adverse trends to management with a remediation plan.
• Coordinated the development of various QA-related metric reports.
• Assisted in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide an assessment of the impact of any deficiencies.

ACADEMIC CREDENTIALS

Education – Master of Business Administration in Total Quality Management from Symbiosis University, Pune | 2011 B. Pharma from Jamia Hamdard University, Pune | 2008

Certification – Pharmaceutical Quality Manager from Institute of Good Manufacturing Practices in India | 2012

PERSONAL DOSSIER

Languages Known: English, & Hindi