With sales of €500m and 2,800 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.
Nemera's manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).
We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.
Job Description
Position Purpose: The Quality System Specialist is responsible for ensuring that the Quality Management System (QMS) is properly maintained and continuously improved in specific areas of expertise, including but not limited to document control, data integrity, and change control.
KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:
Support the Quality Department in specific QMS areas such as document control, data integrity, and change control linked to electronic in process controls that impact regulatory affairs, CAPA management, change control...
Develop and maintain the organization's QMS system for eIPC (electronic in-process control), including policies, procedures, work instructions, and forms, integrating central documentation into the local QMS.
Collaborate with local and central cross-functional teams to develop quality inspection plans in SAP system.
Ensure the QMS is communicated and understood throughout the organization and employees are trained on QMS requirements.
Assess and determine the effectiveness of the QMS and identify opportunities for improvement.
POSITION REQUIREMENTS:
Minimum 1 year of experience within the quality profession (medical device or pharmaceutical preferred)
Highschool Diploma or Equivalent
Experience with SAP
Ability to use software productivity tools such as Statistical Process Control.
Knowledge of ISO 13485 and ISO 14971 (risk management)
Knowledge of digital QMS software
Ability to lift up to 30 lbs.
PREFERRED KNOWLEDGE/SKILLS:
Self-directed and possess excellent communication, oral, and written skills.
Capable of working with minimal supervision.
Ability to apply basic mathematical concepts.
Basic computer skills.
Knowledge of pharmaceutical GMPs
WORK ENVIRONMENT:
Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
Qualifications
POSITION REQUIREMENTS:
Minimum 1 year of experience within the quality profession (medical device or pharmaceutical preferred)
Highschool Diploma or Equivalent
Experience with SAP
Ability to use software productivity tools such as Statistical Process Control.
Knowledge of ISO 13485 and ISO 14971 (risk management)
Knowledge of digital QMS software
Ability to lift up to 30 lbs.
PREFERRED KNOWLEDGE/SKILLS:
Self-directed and possess excellent communication, oral, and written skills.
Capable of working with minimal supervision.
Ability to apply basic mathematical concepts.
Basic computer skills.
Knowledge of pharmaceutical GMPs
Additional Information
Why Join Nemera?
At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients' lives.
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net
Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!
Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at bghr@nemera.net