Place of work:
Michalovce

Salary:
from 1800EUR/month (The final salary depends on the amount of experience)

Contract type:
full-time

Start date:
ASAP

About the role:

R&D Manager is a member of global T&I (Technology and Innovation) team with responsibility for process and product development and project management.

R&D Manager is a critical function for project execution and team management of T&I work streams. The T&I Manager is responsible for project management and assigned resource utilization (both in project and direct reports in T&I Team) with focus on maintaining the T&I workstream flowing. R&D  Manager contributes to development of business strategy as well as all T&I processes in accordance with legislation and expectation of CvT Senior Manager Team. The function leads the individual and T&I team development.

Your key duties and responsibilities:

Internal Audit Process:

• Execute the Internal Audit Process in the organization according to the site schedule
• The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance
• Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements
• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings
• Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances
• Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics
• Gather and analyse data as an input to the Management Reviews to allow meaningful review
• Support Internal Audit and Corporate Audits as required

External Audit Process:

• External audit process execution, from readiness, to execution, response and tracking of commitments
• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance
• Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable
• Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board

Compliance and Education Program:

• Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)
• Coach/train internal auditors
• Keep abreast of all current regulatory and statutory expectations
• Support Regulation/Standard Gap Assessments and implementation as required

Inspection readiness:

• Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation
• Ensure sites are in permanent state of inspection readiness using readiness tools
• Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in
• Performs and lead Gemba walks as part of readiness activities

Health Authority:

• Support External Audits and responses

Other responsibilities:

• Support other projects as required by the business

 

About you:

• Internal Lead Auditor Certification and experience in executing audits
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
• Ability to build and nurture strong and positive relationships with other leaders to partner effectively
• Balanced technical understanding of products and processes combined with business and compliance acumen

 

Education / Qualifications:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required
• Five to Ten (5-10) years in the medical device and/or pharmaceutical industry preferred. We welcome candidates also from other regulated industries
• Two to Four (2-4) years’ experience in a QA/QC role
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Communicative level of English language

Contact:

astell@astell.sk