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Job Title: QA Associate 

 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

 

3-5 years of relevant experience in Medical Devices Industry.

 

 

Area of Expertise:

• To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
• Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
• Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
• Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
• Manage all documentation related to internal and external audit.
• Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
• Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
• Co-ordination of Management Review Meetings & its action items implementation

 

Experience Required:

• 3-5 years of relevant experience in Medical Devices Industry.
• Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
• Ability to read and understand standard requirements independently.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
• Good understanding of design control, and post marketing processes
• Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
• Working knowledge of an e-QMS is an added advantage.

A full time Clinical Research Associate works on clinical trials and other exploratory research projects subcontracted by Alke Research Pvt Ltd. The job requires vibrant and hardworking individuals with a zeal to build a career in the clinical research industry.
Carry out independent site feasibility and selections 
Help with site initiation and trial activation
Carry out independent site monitoring; online and offline
Help with preparing Serious Adverse Event report filing with the regulatory
Provide assitance to site in protocol related queries, ICH GCP Training for site personnel
Be a liasion between the sponsor, investigator and CRO
Support the site prepare and face regulatory audit / site inspections

• Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
• Support in ensuring transition activity is planned and executed to schedule, budget and scope
• Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
• Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
• Keep stakeholders involved in transition process and update them with the progress and roadblocks
• Promote awareness of transition planning and support processes within the GCC
• Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
• Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC

Skills:

• Proven knowledge of service transition methodology, tools and templates through experience or qualifications
• The ability to identify, escalate and manage project risks with the Transition Lead
• 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
• Good exposure in previous roles to multi-cultural, transversal functions
• Pharma background with experience across the systems development life cycle with experience in different project phases
• Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing