Monica Elena Carnateanu
Commercial Quality Manager (Health) and Responsible Person (Rp) Uk & Ireland @Reckitt
Signup · Get unlimited contacts
WORK HISTORY
Commercial Quality Manager (Health) and Responsible Person (Rp) Uk & Ireland @Reckitt
Slough, GB
Responsible to develop and implement the local Quality Management System (QMS) to ensure fully compliant products- Provide leadership on continuous improvement projects, quality initiatives, as established by corporate Quality Management- Work with local functions to develop and maintain all relevant procedures in line with global requirements in a state of inspection readiness- Ensure a system is in place to manage local embellishment, re-pack and co-packing work to meet all regulatory requirements- Ensure a robust change control system is in place to ensure business change management- Ensure a training system is in place and provide training on the local QMS- Investigate quality issues (Non-conformances) and failures (CEP Events) and apply Corrective and Preventive Actions (CAPA) to prevent recurrence- Audit/Inspection Management: ensure that processes are in place to assess the adequacy and effectiveness of the local QMS- Maintain a document control system for local QMS, perform reviews and approve business Standard Operating Procedures (SOP) & Technical Agreements- Conduct mock recall exercises to confirm adequacy of the local recall procedure- Management Review to report level of compliance of local QMS, Policies and GDP regularly to Management Team and drive closure of gaps to maintain compliance- Support Consumer Relations and Customer Services with complaint handling procedures and systems to ensure effective feedback to the business- Responsible for initial compliance assessment and approval of Distributors & Embellishers- Ensure Technical Agreements (TAs) are in place for all Distributors and Embellishers- Work with regional and Supply Quality teams to ensure implementation of appropriate controls for consistent quality of products- Co-ordinate and host external inspections by External Authorities, third-parties, follow ups and responses after external inspections.
EDUCATION
Carol Davila University of Medicine and Pharmacy
Resident in General Pharmacy
Academia de Studii Economice din București
Master in Marketing and Business Comunication
Carol Davila University of Medicine and Pharmacy
Bachelor of Science (BS)
SKILLS
ABOUT MONICA ELENA CARNATEANU
With over 20 years of experience in the pharmaceutical industry, I’ve built a strong foundation across pharmaceuticals, medical devices, and cosmetics, specialising for the past decade in Quality Assurance and Good Distribution Practices (GDP), working with a wide range of pharmaceutical, medical device and cosmetic processes and regulations.Eligibility to act as an RP and RPi in the UK.Bachelor of Pharmacy, Masters of Pharmacy.Specialties: Primary Pharmacist in General Pharmacy, Quality Assurance Management, Auditor in quality management system in the pharmaceutical industry, ISO 13485 Medical Devices Internal Auditor, certified Trainer.Committed and highly motivated professional for significant contribution to achieve quality compliance and excellent audit results. Can-Do attitude, focused on results, positive, fast, energic, flexible, open to changes, have the ability to work independently and collaboratively within a team, team player.Internationally mobile employee.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.