Cetas Health invites application for the post of Quality Assurance Lead/ Manager for Mumbai Location.
About Cetas Health
Cetas Healthcare is a global firm specializing in customer insights and strategy for the medical devices industry. Cetas Healthcare is a preferred market research vendor for many of our Med Tech clients. Preferred primarily for expertise in MedTech industry AND for the capability to design and execute complex market research studies in multiple countries.
- Qualification Criteria – Graduate/PG.
- Experience – 5+ years in quality and compliance.
- Own Cetas’s quality management especially on developing and implementing quality parameters.
- Serve as the author and/or process owner of Quality Standard Operating Procedures (SOPs) as assigned to ensure compliance with regulatory requirements
- Single point of contact (SPOC) to control and maintain the SOP repository of Cetas
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to the management for continuous process improvement
- Train the employees on all quality related SOPs
- SPOC to create & circulate the quality review calendar to all relevant stakeholders
- Perform all quality reviews basis the quality review plan of the quality SOP and set up a continuous feedback loop by regularizing the quality huddles
- Escalate major quality gaps on time and to ensure timely mitigation of gaps
- Continuously work with internal and external clients to ensure satisfaction
- Ensure training excellence by building a feedback loop post reviewing of archive training related documents
- Prepare quality reports at aligned frequency for internal quality management and as required by Cetas partners
- Updating the audit manager on repeated gaps observed during quality reviews. Collaborating with the audit manager to perform audit
- Driving automation of Quality Management System (QMS) within Cetas to improve efficiency & reduce margin for error
- Responsible for facilitation of implementation of technical controls required within their team
- Ensure timely reporting of Information security incidents observed by their team
- Creation, review and updating 1) Function specific DLP rules 2) Information security risk register 3) Information handling schedule
- Supporting organization in any Information security related activities that need to be implemented at employee/functional level.
- Authorization of:
- Responsible for monitoring and updating policies and procedures to include regulatory changes and any recommendations from partners.
- Responsible & Accountable for planning and driving quality improvement process.
- Responsible to review the company wide training records, share the feedback with the respective team and ensure the corrections are performed and closed on time.
- Ensure that all the CAPAs identified through internal audit, regulatory or partner audit needs to be closed on time and archive all the records in restricted folder.
- Excellent communication and time management skills to manage multiple projects at any one time.
- Should have good understanding on ISO 9001, ISO 20252, GDPR, Risk management & BCP, stay abreast with the latest laws and updates on a regulatory & industry best practice front.
- 100% SOP management (in terms of on time review/ availability/ archival/ transfer/ training.
- 100% management on quality review & feedback process & archival of all related documentation.
- Timely completion and archival of CAPA & associated evidences.
- Passing global and other related audits.
- Support in achieving certification to make Cetas a globally recognized lead in Healthcare Market Insights.