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Quality Assurance Manager
3 months ago
Candidates are requested to read the Job-post properly and thoroughly before applying
Role:- QC Manager (Mid-Senior Role)
No of opening:-1
Location:-Chennai
Experience Required: Minimum 7+ years Experience in IVD Medical Devices / IVD Diagnostic Reagents/Kits Industry, including at-least 3years in QC.
Education Qualification: MTECH in Biotechnology / Biopharmaceutical Technology or PhD
Key Skills required:
• Prior Experience in QC, including thorough knowledge of manufacturing processes for IVD diagnostics kits & reagents manufacturing.
- Should possess strong interpersonal and communication skills
- Good relationship management skills: Should be a good team player and complete the activity on time within project timelines.
• Should have an Goal-oriented Mindset.
• Superior organizational skills: Must have ability to work efficiently in a fast-paced multitasking work environment and prioritize tasks effectively & efficiently.
Roles & Responsibilities
- In-depth knowledge of manufacturing processes for IVD diagnostics kits & reagents manufacturing, the QMS & Regulations including ISO 13485, Indian MDR, CE-IVD, US FDA, and EU MDR regulations to ensure adherence to cGMP & cGLP protocols.
- Establish and maintain quality management systems to support product development, manufacturing, quality control and distribution processes.
- Preparation and periodic revision of Standard Operating Protocols (SOPs), Specifications, Quality Standards, Work Instructions, Validation Methods & Protocols and other Technical Documents.
- Provide training support to fellow team-members regarding quality assurance procedures, regulations, and documentation requirements, and distribute necessary Forms, Logs and other QC documents in all departments.
- Generation & Maintenance of Analytical Records: Ensure that all documentations are prepared and maintained as per regulatory standards and ensure proper execution of analytical method transfers and Validation of Analytical methods.
- Cross-Coordinate with Scientific & Production Teams for method transfer activities and complete the method-transfer activities on time.
- Periodic Review of all Analytical QC test reports (input material, in-process, finished products & stability)
- Ensure Regular Monitoring of Laboratory Environment (Temperature, Moisture/Humidity, Cleanliness, Fumigation details etc.) and make timely data entry and maintain the records.
- Ensure Proper Maintenance & Calibration of pipettes and other essential equipments /instrumentations in the Laboratory and coordinate with fellow team-members in material management team who’re handling reagents supplies/inventories and maintenances.
- Ensure proper Logging-in and documentation of QMS Elements (incidents, change controls, deviations, CAPA, post CAPA validation etc.) related to IVD product designs and IVD products QC standards.
- Report & make record of any reagent malfunctions, gaps/ deviations in procedures and report any unsafe conditions.
- Independently lead and handle risk management activities including handling of any laboratory incident investigations, change controls, deviation investigations, and CAPAs. Must independently take timely decisions, and notify, record the note of actions taken, and ensure appropriate risk mitigation measures are followed.
- Must independently arrange periodic Inter-Departmental QC Audits and inspections to ensure adherence to regulatory requirements and Medical/IVD Quality Standards.
- Must Serve as Primary Point of Contact for regulatory agencies during external inspections and audits and must be able to independently handle such external audits.
- Coordinate with cross-functional teams (Wet-Bench Research Lab, Manufacturing Team & Bioinformatics Teams) to provide analytical support according to the project needs, and as per the regulatory standards.
- Stay up to date with evolving regulations, industry standards, and best practices related to medical device quality assurance.
Other Additional Responsibilities
- To Oversee the adherence to QC standards at all levels:
(a) Receipt of Samples / Input Reagents, Logging & Data Entry of the receipt of samples, barcoding and generation of unique analytical reference number for each sample and storing all input Samples in the designated location.
(b) Compartmentation/ reservation of Sample Storage Space for various In-Process stages for each products.
(c) Ensure proper storage spaces for finished products/kits and post-manufacturing QC Testing.
(d) Oversee the adherence to Schedules & SOP for QC Testing: Ensure that the schedules and SOPs provided are followed for testing, testing of materials (input, in-process, finished products/kits & stability) in adherence with quality standards & compliances, and ensure proper updation / documentation of each testing status.
(e) Review Sample Management Protocols: Ensure QC standards on sample processing, Aliquots prepared and reagents used in Molecular Biology, & ensure proper reconciling, discarding of samples after test completion & review / retesting.
(f) Review of the maintenance of COA & MSDS all chemicals, reagents available in the laboratory inventory and coordinate with fellow team-members ensure timely procurements of chemicals and reagents
Brief about Acrannolife:
Acrannolife Genomics Private Limited is India's fastest growing clinical genomics & precision diagnostics technology company dedicated to enhancing disease diagnosis through innovative molecular diagnostics. With a mission to positively impact over a billion lives, Acrannolife Genomics leads with purpose and passion, focusing on developing a technology platforms for detecting and monitoring chronic and infectious diseases. Our goal is to disrupt the current healthcare process by enabling quick, early detection, decentralizing testing, and democratizing access to essential healthcare globally.
Through innovation and cutting-edge technologies, we address the most ambitious and complex challenges in healthcare, revolutionizing the early diagnosis of chronic and infectious diseases. Our dedicated global team of scientists is united in pursuing moon-shot challenges, striving to deliver improved clinical outcomes and positively impact lives.
Acrannolife Genomics Private Limited is setting new benchmarks in the healthcare industry with its unwavering commitment to improving disease detection and patient care, with utilizing state-of-the-art technologies such as liquid biopsy and Loop-Mediated Isothermal Amplification (LAMP). Groundbreaking products like COVIQWIK and the Trunome Technology platform position the company to drive significant advancements in precision diagnostics, making a substantial impact on countless lives.
The Trunome Technology platform boasts nearly 100,000 unique biological datasets, profiled through high-throughput biological assay, offering a novel approach to diagnostics & biomarker discovery. Additionally, Trunome houses a large repository of Omics datasets, further enhancing its capabilities in precision medicine.
The company’s unwavering dedication towards innovation and patient-centric approaches has earned it significant recognitions. Acrannolife has been felicitated by the Hon'ble President of India for the contribution of COVIQWIK and also received multiple other prestigious awards for the contributions to healthcare. Among these accolades are being named one of the top innovative startups by the India Innovation Growth Program (IIGP) and winning India’s biggest innovation competition, the ET-POI in 2016, as well as the Best Healthcare Start-up Award in 2024 by the Economic Times. The Trunome Technology Platform was also showcased in Shark-Tank India Season-2, with a 4-Sharks Investment Win.
Team: You will be joining a multi-disciplinary team consisting of Medical Doctors, Laboratory Scientists, Laboratory & IVD manufacturing technologists and Bioinformaticians. You will also be working alongside with other cutting-edge teams working with us from across the world.
Other Value-Added Perks, Benefits, Rewards & Propositions on Working with us:
•Competitive Pay as per Industry standards
•Opportunity to work on Most Novel & Innovative projects, including, some US-based global projects.
•As a Startup, we would be offering the Freedom to Think, Innovate, Work & Expand your Skills: You would be Working with a team of ‘rockstars’ and bring about the best in You..
•Full support and career development resources to expand your skills, enhance your expertise, & maximize your potential along your career journey: You get the Latest and Best hardware support.
•Opportunity for Research Publications in Standard, International Medical & Scientific Journals.
•Handsome Rewards – Comprising of Health Insurance, Work-Life Balance with a good sick & Maternity Leave Policy, Career benefits & growth including Performance-linked benefits & Bonuses, and Flexible-timings depending on real-time needs.
•2-DaysVacation Travel Surprises per Year to an Unique Indian destination for hard and high performing employees.
•A set of different indoor games, including Fun Fridays.. All work and no play make Jack/Jill.......
•Diverse and Inclusive Community with an Open, transparent work culture that includes weekly meetings wherein the Teammates are empowered to bring-in and discuss on innovative, out-of-box ideas & solutions.
•A variety of amenities within campus (Restaurant, Bank-ATM, open terrace to relax, Bean Bags etc).
•Free On-site EV-charging for all EVs, including EV-Bikes & Cars.
•And at the last, but not the least, the most important benefit: An immeasurable opportunity to indirectly or directly Bring about a positive change towards the lives of hundreds of millions of patients.
Do Email your Resumes to: hr@acrannolife.com
