QA Engineer
We are currently recruiting for a QA Engineer at our Dardilly, France.
The QA Engineer is needed to manage the subcontracting site of GANA and acts as the representative of the legal manufacturer.
The ideal candidate must have expertise in lyophilisation process and 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.
Hours of work
- 35
Location
Dardilly, France
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
Our Mission
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Our Values
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
Key Responsibilities
- Activities related to Quality Management system
- Maintain a close follow-up on subcontracting activities
- Manage the subcontracting contract with GANA
- Perform audit of the contract manufacturing site, log audit NC in the Corporate system and ensure follow up of the CAPA plan in collaboration with Gana
- Review and approval of the process and product validation protocols and reports (manufacturing process, sterile barrier, stability…)
- Ensure production nonconformity assessment, log of the NC and CAPA in the Corporate system and ensure follow up of the CAPA plan in collaboration with Gana
- Ensure change control assessment, log of change controls in the corporate system and ensure follow up of the CC plan in collaboration with Gana
- Activities related to Regulatory Affairs
- Technical support to Sinclair's Regulatory Affairs and Corporate Vigilance department for the maintenance of approvals and registration certificates of Lanluma products
- Prepare for and support in regulatory audits and inspections
- Conformity verification and approval of EC declarations of conformity and technical documentation relating to Lanluma products
- Activities related to Materi vigilance
- Participate in the handling of customer complaints and Materi Vigilance cases in collaboration with the Quality and Corporate Vigilance Sinclair departments and with Gana for investigations
- Participate in the validation of security measures in collaboration with Corporate Sinclair
- Review and approval of Materi Vigilance reports prior to submission to the authorities
- Review and approval of declarations and safety measures submitted to the authorities: Field Safety Notice, Field Safety Corrective Action, recalls/batch withdrawals
- Participate in post-trade surveillance activities in collaboration with Corporate Sinclair and ensure that appropriate corrective and preventive actions are implemented
- Activities related to Risk Management
- Review of the QMS risk management process from GANA
- Participate in product risk management activities in collaboration with Corporate Sinclair
Your Skills & Experience – Do You Have What it Takes?
Essential
- Expertise in lyophilisation process
- 4/5 years' higher education in a scientific and/or quality control field
- 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department
- Fluent English (written and spoken)
- Good command of IT tools (Word, Excel)
- Based closed to Lyon or agree to move close to Lyon
Desirable
- At least 1 years’ experience in the field of injectable products
- Knowledge of the Medical Device Regulation 2017/745
A bit about you – do you fit this description?
Role competencies
- Knowledge of Lyophilisation
- Knowledge in Audit process
- Knowledge in NC/CAPA process
- Knowledge in Change Control process
- Knowledge of Medical Devices regulations (MDR 2017/745)
- knowledge of pharmaceutical standards
General competencies
- Teamwork
- Taking the initiative
- The search for continuous improvement
What We Offer
We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.
This is an exciting opportunity to join a successful company, with big ambitions for the future
- If this sounds like you and you meet the requirements, please apply, we would love to hear from you.
Please note if we receive a high volume of applications, we may close the role before the closing date noted.
By making this application you give consent for personal information to be used in automated decision making processes relating to key job requirements which are stated in this ad.
If you have any questions, please email .
Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.