Sr. Executive Quality Management - WIIPL Pvt. Ltd. - Noida
(2024-11)
Medical Devices Manufacturer
- Led and direct all quality assurance activities for company.
- Overseas procedures for internal data validation audits, development, data and outcomes management for all contract programs.
- Compile report and identify trends or area requiring additional actions.
- Develops 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 sites selection and activation of research and development laboratory centres.
- Manage interface with Quality Compliance audit team to direct support audit, due diligence, and inspection readiness plans.
- Buildup relation
- Administer internal audits and provides support for external inspections.
- Develop new and improved processes in collaboration with other QMS process.
- Coordinate with plants, RA and labelling and other internal supervisors, functional peer and senior leaders and lead interactions with regulators and customer to represent the company products and processes.
- Identify and direct continuous improvement projects to achieve quality, reliability, and cost improvements.
Quality Cum Regulatory Manager - Recombigen Laboratories Pvt Ltd - New Delhi
(2020-08 - 2024-11)
IVD Manufacturer
- Reviewing and approval of QA-controlled documentation (such as SOPs, batch records, working instructions).
- Support for the development of appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities.
- Maintenance Calibrate & conduct preventive maintenance plan. Documents Issuance and control of documents as per SOP.
- Preparation of SOPs for QA department. Review of Batch manufacturing record and coordination till release of the product.
- Handling of QMS like Change control, Deviations and Market complaints. Review artwork.
- Apply for license on CDSCO, prepare the reply of receive queries and NSW for rapid card, pregnancy kit and other testing strip.
- Build new processes from scratch for production hurdles.
- Organized and executed the program for internal and external audits.
- Review design and design changes, protocols and document change requests.
- Influenced the decision-making process to ensure quality requirements.
- Supported the development, implementation, maintain ace , 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.
- Participated in oversight and management of investigator site Audits, Internal Audit and Vendors Quality programs with guidance from management.
- 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.
CQA Manager - Bristol Myers Squibs India Pvt Ltd C/O Spark Enterprises - New Delhi
(2014-05 - 2020-06)
- Quality System Development: Creating, implementing, and maintaining quality policies, procedures, and standards across all company verticals.
- Audit and Compliance: Planning and conducting internal/external audits to ensure compliance with industry standards (ISO 9001) and regulatory requirements.
- Performance Monitoring: Tracking key performance indicators (KPIs) to monitor quality performance, identify trends, and evaluate product quality.
- Root Cause Analysis: Investigating quality issues, customer complaints, and non-conformities, then implementing corrective and preventive actions (CAPA).
- Team Leadership: Managing teams, providing training on quality methodologies, and promoting a culture of quality awareness.
- Documentation Management: Ensuring all quality-related documents, test records, and reports are updated and maintained.
- Vendor Quality Control: Reviewing and auditing the quality systems of suppliers and contractors.
- Customer Satisfaction: Ensuring the final product meets or exceeds customer expectations.
- Cost Efficiency: Reducing costs by lowering waste and rework.
- Risk Mitigation: Identifying potential risks and implementing preventive controls.
Pharmacist (Internship) - AASTHA HEALTHCARE
(2012-05 - 2014-07)
- Responsibilities include Receiving clients about the dosage, benefits, side effects, and contraindications attached to each drug. Selling items to medical professionals, hospitals, and pharmacies based on their needs.
- Delivering samples to entities who are serious about purchasing our drugs. Creating promotional materials such as banners and informative cards for dissemination by clients.
- Serves customers by selling pharmaceutical products and meeting customer needs.
- Submit orders by referring to price lists and product literature.
- Keeps management informed by submitting activity and results reports, such as daily call reports, weekly work plans, and monthly and annual territory analyses.
- Monitors competition by gathering current marketplace information on pricing, products, new products, delivery schedules, and merchandising techniques.
- Recommendations for changes in products, service, and policy by evaluating results and competitive developments. Resolves customer complaints by investigating problems, developing solutions, preparing reports, making recommendations to management. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
- Provides historical records by maintaining records on area and customer sales.
- Instructing patients on how to take medication, managing chronic conditions, and answering questions about over the counter (OTC) options.
- Maintaining detailed, secure patient records, managing inventory, ensuring compliance with legal regulations, and managing insurance claims.
Territory Manager - CIPLA PVT. LTD - KANPUR
(2011-10 - 2012-04)
- Traveling throughout an assigned territory to train and guide company sales representatives.
- Maintaining solid working relationships with customers by ensuring that their needs are met and resolving complaints in a timely manner.
- Continually meeting or exceeding sales targets by persuading customers within an assigned territory to purchase company products and services.
- Analysing sales and marketing data to determine the most effective sales and marketing techniques.
- Developing innovative sales strategies to increase sales within an assigned territory.
- Conducting surveys to better understand customer needs.
- Attending trade shows to promote company products and services.
- Ensuring that brand awareness within an assigned territory meets company expectations.
- Motivating Sales Representatives to achieve sales quotas and evaluating their performance based on their ability or inability to achieve sales quotas.
- Monitoring competitors' sales activity within an assigned territory.
