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CAPA Coordinator
Unomedical s.r.o.
Priemyselný park 3, Michalovce
full-time
by agreement
1 450 EUR/monthMinimum 1450€ / monthly (depending on experiences and quality of the candidate) + annual global incentive plan-bonus and other benefits in compliance with social benefit program of the company.
Information about the position
Job description, responsibilities and duties
The role:
To ensure proper CAPA and Nonconformity handling
Lead investigationteams eitherin case ofcorrective CAPA initiation or in case of preventive CAPA initiation to prevent the potential nonconformity occurrence
Determine and develop methodologies to achieve specific goals and business objectives (eg KPIs)
Key Responsibilities:
- Help to lead and coordinate activity of Investigation and root cause analysis to determine likely cause(s) of Non-Conformance
- Develop and document plans to address correction (if applicable) and Corrective Action/Preventive Action activities
- Prepare plan for effectiveness check activity
- Review and approve activity related to: CAPA opening, NC opening, Action plans, Investigation and Root Cause analysis, Investigation and Root Cause analysis
- Lead owners so that the investigation and action plan would be prepared correctly
- Decide what corrective or preventive action has to be taken
- Decide verification activity and effectiveness metrics
- Communicate CAPA status, trending, criticalityto themanagement team
- Conduct analysis and make evaluation of trends
- Lead CAPA meetings
- To assist in making decision what action is necessary to do in case of nonconformity is observed
- Decide of the need for opening CAPA action
- Conduct analysis and trending in NC
- Come up with suggestions for improvements
- Monitor trends and initiate CAPA in case it is necessary.
- To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the company's targets in the EHS area
Authority (if applicable):
- Make decision to open and close Corrective and/or Preventive action
- Decide to return process of corrective or preventive action back in case more work is required
- Delegate investigation and preparation of CAPA plan to CAPA Owners
- Lead owners for fulfilment of all CAPA requirements
- Decide or verify the decision about product final disposition in case of nonconformity
- Coordinate overall activities within non-conformity handling
- Open NC resulted from internal audit or external audit readiness process
Employee perks, benefits
Employee perks, benefits:
- Annual global incentive plan-bonus.
- Large corporation with representation and manufacturing plants in the world.
- Stable employer for Michalovce city and its surroundings.
- Corporate culture – Underpinning everything we do are our values:
- Improve care
- Deliver results
- Grow together
- Own it
- Do what´s right
- Convatec Day – extra day off.
- Home office possibilities.
- Flexible working hours.
- Introduction program according to company standards.
- Development trainings.
- Career opportunities for internal employees.
- Referral bonus system.
- Recognition program.
- Meals in the amount of 0.44 Eur per one meal unit / day.
- Supplementary pension plan after the trial period with the employer's contribution.
- Social fund (various support and perks for employees).
- Free bus transport within Michalovce city.
- Various events / team building activities for employees.
- Various employee discounts by vendors within Michalovce city.
Working Conditions:
- Work in office environment, production centers and laboratory
- Availability to travel, international and national.
Information about the selection process
Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law.
Information about personal data processing of job seekers is located on link: https://www.convatec.com/sk-sk/o-nas/kariera/
Requirements for the employee
Candidates with education suit the position
Educational Specialization
Language skills
Personality requirements and skills
Skills & Experience:
Knowledge and experience, of at least 2 years, of change control principles and associated processes
Knowledge of complaint handling, CAPA and associated processes.
Ability to handle inspections by regulatory bodies (e.g. FDA, ISO)
Ability to use statistical techniques to identify robust processes and improve existing processes
Qualifications/Education:
Master degree at technical University
At least 2 years of minimum experience in a leadership role, preferably in the Medical Device, Healthcare industry or Food industry.
Knowledge of MDSAP, ISO 13485, MDR – preferred
Computer skills – Excel, Word, Outlook, Minitab, Quality Companion, Proficy Shop Floor, Power Point
Flexibility, creativity, communicativeness, team work, leadership
Preferred training requirements:
Introduction training for administrative employees
Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required
Quality System documents and procedures relevant to job performance
Languages
- Speaking: Yes English*
- Writing/Reading: Yes English*
*additional languages as required or nice to have
Advertiser
Brief description of the company
To find out more please visit https://careers.convatec.com - thanks for your interest!