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Quality Assurance & Regulatory for Medical Devices (Cell therapy / Bioprocess / BMT)
Job opening for Executive / Sr. Executive / Asst. Manager / Manager for Quality Assurance (QA) & Regulatory for Medical Devices
Reporting to: Head Quality and Regulatory
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Location: Chennai
The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with regulatory affairs.
Roles and Responsibilities:
- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, USFDA, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and post-marketing surveillance studies. Clinical evaluation studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.
Experience:
- Quality assurance/ Regulatory affairs experience: 5 years exp. in writing technical documentation’ role in medical devices preferred.
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.
Send your resume to: [email protected]
Quality Assurance & Regulatory Affairs Executive: Cell therapy/ Bioprocess/ BMT
Reporting to: Head Quality and Regulatory
Location: Chennai
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Roles and Responsibilities:
- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and
- post-marketing surveillance studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.
Experience:
- Regulatory Affairs Experience: 2 – 4 years’ experience in writing technical documentation’ role in medical devices preferred
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.
Send your resume to [email protected]
Quality Control Executive
Reporting to: Head – QC
Location: Chennai
Education: B.E/ B. tech in biomedical engineering / Biotechnology/MSc – Chemistry /B. Pharm
Roles:
To work in Quality Control activities of the Lab with regard to Testing of Raw Material, In process, Finished Products, documentation and quality management system requirements at Quality Control lab. To ensure that the requirements of MDR, ISO 13485, ISO 3826, USFDA QSR – CFR Part 820 and such other international standards are implemented and maintained. Handle regulatory and customer audits and customer requirements related quality and other statue.
Responsibilities:
- Ensure all phases of a manufacturing and other handling process meets the standards or requirements of the quality plan including in-process check.
- Play an active role in all stages of the production process (Raw Materials Analyst), during production itself (In Process Analyst) or at the end of manufacture (Finished Product testing).
- Timely completion of all experiments according to established Standard Operating Practices (SOPs), and also Good Laboratory Practices (GLP) or Good Clinical Practices (GCP), ISO/ EN standards for highly regulated industries.
- Basic lab-work and use of chemical/pharma/microbiology testing equipment and processes.
- Prepare technical documents that report the results of their lab work. (Batch release records, sterility data, stability data, validation data)
- Responsible for minor equipment troubleshooting, calibration and repair.
- Establish specifications for conducting assays and writing standard operating procedures.
- Follow practices/ documentation pertaining to MDR and all applicable statutory requirements
- Responsible for QMS elements viz. Change control, Deviation, CAPA etc. and its tracking for closure.
- Monitoring of supplier performance/ compliance documents (Audit response/CAPA) and support the team in taking informed decision on approving the supplier/vendor/service providers
Qualifications and Skills Necessary:
- Master’s degree or equivalent (or higher) in chemistry/ plastic engineering/ polymer science/ microbiology or Biotechnology.
- Ability to work both in a team or individually and good mathematical skills are all required.
- Proven knowledge of methods/techniques of medical devices. ISO 3826
- Experience in Medical devices QMS ISO 13485 and wet lab/ instrumentation.
- Hands on experience in EN-ISO 13485, EU MDR, CE marking, USFDA QSR – CFR Part 820 and such other international standards.
- Experience in handling audits/ inspection of Indian medical devices rule requirements.
Send your resume to [email protected]
Job Opening for Chief Financial Officer
The ideal candidate will be responsible for financial strategy, financial planning and analysis, financial reports, company audits, compliance, and bank relationships. They will collaborate with the CEO and the executive team to make decisions regarding company’s financial strategy and operations. The candidate will possess a strong background in finance and management.The CFO will play an active role in the budgeting and planning function. Formulate and evaluate all financial planning activities / processes including operating and strategic plans forecasts. Managing strong financial strategy to implement and monitor overall financial plans and accounting practices of the Company to ensure adherence to our business plans. Leading the budgeting and planning process and track performance against budgets, sales, and monitor investments and cash flows. Responsible for contracts and procurement, Internal Audit & Risk management, Liasioning Provide financial and business inputs for effective decision making and lead post implementation reviews. Control and monitor the revenue assurance function to ensure maximization of revenue.
Responsibilities
- Creating Tax Strategies to reduce obligations
- Monitoring strategic business plans
- Financial strategy development
- Manage the company’s budgeting, accounting and financial planning
- Making sure company is in compliance with all regulations
- Plan and perform risk management duties
- Plan, implement and manage investment strategies
- Prepare and present forecasting reports
- Overall handling Finance and Accounts department
- Analysis and assessment of capital required over the plan period and arranging finance
- Develop and maintain accurate and effective financial statements.
- Responsible for complete tax planning, tax compliance and monitoring other taxation issues for the company.
- MIS Reporting
Role: Head/VP/GM-CFO/Financial Controller
Industry Type: Medical Devices
Functional Area: Finance & Accounts
Qualifications
- Strong finance-based analytical skills
- 7 – 10 years’ of finance experience
- CA / MBA / PGDM in Finance
Please send your resume to [email protected]
Sales Manager – Single Use Disposables
Job Locations: Bangalore, Hyderabad, Pune
Roles and Responsibilities
- Present, promote and sell Single use disposables products/services to existing and prospective customers
- Performs market research and analysis, to understand existing market share and create a stronger name in the space
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the territory/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory sales.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- And ensure proper Branding & Campaigns for sales improvement.
Desired Candidate Profile
- 2-5 Years Sales experience in single use disposable products (medical devices) in India.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to [email protected]
National Sales Manager (BMT & Transfusion)
Roles and Responsibilities
- Present, promote and sell Bone marrow transplant (BMT) and Transfusion products/services to existing and prospective customers
- Performs market research and analysis, to understand existing market share and create a stronger name in the space
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the territory/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- To formulate a specific budget and expenditure plan the new Business Plans
- Team Building Collaborate with Sales department to ensure proper Branding & Campaigns
- Conduct product training to sales team and manage products/brands.
Desired Candidate Profile
- Should have handled BMT and transfusion products/ services in India for five years.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to [email protected]
National Sales Manager – Medical & OEM
Roles and Responsibilities
- Present, promote and sell medical devices to existing and prospective customers
- Identify and develop original equipment manufacturer (OEM) business for manufacturing.
- Performs market research and analysis, to understand existing market share and create a stronger name in the space for medical devices.
- Update management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Analyze the National level/markets potential, track sales and status reports
- Maintain an updated database/MIS Report for the assigned territory.
- Maintaining positive business relationships to ensure future sales
- Achieve agreed upon sales targets and outcomes within schedule
- Monitors external and internal environment for development of new market segments and new products
- To formulate a specific budget and expenditure plan the new Business Plans
- Team Building Collaborate with Sales department to ensure proper Branding & Campaigns
- Conduct product training to sales team and manage products/brands.
Desired Candidate Profile
- Should have handled Medical products and OEM services in India for five years.
- Team Player ability to work as a part of team and problem-solving skills
- Excellent selling, negotiation and communication skills
- Highly motivated and target driven with a proven track record in sales
- Monitor competition and provide suggestions for improvement
- Planning and organization skills and strong analytical abilities
- Relationship management skills and openness to feedback
Education: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, B.Pharma in Pharmacy, MBA
Send your resume to [email protected]
We are hiring Digital Marketing Executives
Job Description
- Planning, execution, and optimization of online marketing strategies.
- Maintain a strong online presence for our company.
- Ability to implement online marketing strategies through social media accounts.
- Achieve superior customer engagement and intimacy, website traffic and revenue by strategically exploiting all aspects of the social media marketing roadmap.
- Develop original content and suggest creative ways to attract more customers and promote brands.
- Increase web traffic and customer engagement metrics aligned with broader marketing strategies.
- SEO Keyword planning and Content Writing for websites and Blogs.
- Creating effective Social Media Plans.
- Conducting Campaigns & Contests for various Social Media Platforms.
- Creating reports showcasing Web Analytics data and site evaluation.
Key skills
- Digital Marketing
- Social Media Marketing
- SEO
- Online Marketing
- Web Analytics
- Article Submission
- Email Campaigns
Send your resume to: [email protected], [email protected]
