- Direct , organize an coordinate RA &QA activities in India & Neighbouring countries (India & SriLanka – mandatory regulatory , other countries: Bangladesh, Nepal, Maldives and Mauritius) sales organization to ensure business is conducted in compliance with regulatory, quality, safety , health and environment requirements required in each country
- Develop and improve RA&QA standards and procedures to achieve organizational efficiencies and ensure optimal value to Business.
- To ensure products are registered according to plan for India and neighbouring markets and maintain appropriate records for product compliance bodies (like CDSCO, MDR2017, IVD directives, CE, BIS ,electrical safety
- To maintain regulatory system update and data compliance on Veeva vault RIMS
- To ensure that necessary licenses and certifications are kept updated and renewed as per plan and timely circulations of licenses.
- Keeping up to date with company's product range.
- Knowledge of SUGAM portal handling /CDSCOMDOnline.
- To coordinate and prepare submission of new, variations and renewal of registration, licenses and tracking.
- To assist customer notification including reports to authorities and manufacturing division and in the event of product quality problems, product recall and similar notification.
- To ensure product corrective action timely implemented.
- To maintain post market vigilance activities records & database (registration master database, customer product complaints, ICCR & product quality issue
- To ensure compliance to relevant environmental, health and safety regulations.
- To ensure compliance to code of conduct and business ethics codes.
- To maintain ERP product restriction due to regulatory requirements.
- To Support Tender submissions by providing Regulatory and Quality documents.
- To liaise with internal customer and division for any regulatory updates and changes.
- To liaise with regulatory authorities like CDSCO (DCGI office), NIB, NPPA, BIS, MieTY, BGFT etc.
- To support RA-QA Manager in maintaining the QMS up to date and QMS system implementation according to ISO 9001 & ISO 13485 & ISO 14001.
- Monitoring and support of ongoing development and implementation of a quality system, focused on continual improvements.
- To support and liaising with internal and external auditors and ensuring execution of corrective action.
- To support QA improvement plans are implemented and maintain.
- Review of labelling and mock up packaging materials labels for accuracy and completeness.
- Contribute to the business-wide quality strategy and quality objectives by providing them reports and quality metrics as and when required.
- Monitor and communicate significant quality trends and identifying adequate corrective actions for IVD segment.
- Provide internal awareness of noted trends and quality issues via periodic and ad hoc reports.
- Knowledge of applicable regulatory requirements, SOPs and company's Corporate Standards.
- Supporting other commercial activities such as supplier qualification, and audits.
- Working closely with local, Global and regional RA & QA team of Asia Pacific and Regional Quality team to streamline process.
- To support conducting management reviews with the Country Leadership Team on quality metrics and objectives.
- Degree in , M. Pharm , in pharmacy
- 4-6 years of experience in a multinational organization and 5 years of RA and QA in a regional sales and Distribution organization
- Required hands-on experience in SAP for RAQA
- Require good experience in Veeva vault RIMS
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RA Specialist II - Gurugram, India - Bio-Rad
Description
Overview
The RA specialist position will be responsible for:
How You'll Make an Impact:
Regulatory Affairs : 70%
Quality Assurance : 30%
What You Bring:
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees through the various stages of an employee's work and life cycle. We're proud to offer a variety of options, including competitive insurance plans for you and your immediate family, Annual Health checkup , Marriage Leave, Paternity Leave ,Employee Assistance Programme , extensive learning and development opportunities, and more.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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