Quality & Regulatory Specialist Job in Prognostics In-med Pvt. Ltd

JOB DESCRIPTION

Quality Assurance

Develop and maintain GCP/ICH/GMP/ISO compliant processes which control the quality of Medical Device Development and clinical trials conducted at In-Med Prognostics.

Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits.

Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.

Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.

Assist with management of contract auditors.

Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.

Assist in providing training to In-Med staff.

Participate in the review and installation of technology products and equipment.

Maintain SOPs and document Control Process at In-Med.

Actively involved in Planning and Review of Design and Development and Risk Management Processes at In-Med.

Regulatory:

Prepare and submit applications andreports tovarious regulatory authorities for Clinical Trial applications as well as Medical Device Registration.

Submit supplements and amendments to update registered product information.

Coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration and other regulatory authorities.

Review, evaluate, and compile files and reports for submission.

Develop and implement strategies for the earliest possible approval of regulatory submission.

Expedite approvals of product and services.

Prepare responses to inquiriesfrom regulatory authorities.

Provide guidance to project teams and staff.

Review of all FDA and other RA policies and updates and communicate to the team

Skills/Qualifications

Demonstrates strong analytical, problem solving skills.

Strong written and verbal communication skills.

Detail oriented, good organizational traits.

Self-motivated, with strong leadership abilities.

Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.

Good computer skills; inclination to adopt technology to maximize efficiency.

Education and Experience:

Bachelors Degree in pharmacy/Life Sciences or equivalent.

At least 2 year experience in the Pharmaceutical Industry and or Medical Device Industry with an in-depth knowledge of US, EU and International regulatory standards, and GxP Guidelines for the conduct of clinical trials/Medical Devices.

1 plus year working in a Quality Control / Assurance area.

Experience and knowledge of medical device Quality System Regulations or ISO Standards.

Experience including external/CRO, clinical/regulatory and document auditing highly preferable

Location Pune