CordenPharma is a leading Contract Development & Manufacturing (CDMO) partner with approximately 2’000 employees across Europe and the United States and annual revenues > 500 M€, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives.
Founded in 1987, CordenPharma Brussels, formerly Peptisyntha, was a member of the Solvay group until being acquired by CordenPharma in October 2013. CordenPharma Brussels has built a 30-year track record of success in supplying pharmaceutical and biotech companies with clinical and commercial scale cGMP peptide APIs.
Through expertise and capabilities in all synthetic peptide-manufacturing technologies, CordenPharma Brussels assesses and customizes its manufacturing approach to achieve the most effective manufacturing process for its customers.
As QA Compliance Specialist you will participate in projects and activities that support the top and bottom line growth of the company through compliant improvement activities.
You will support quality compliance activities and initiatives through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate governmental and regulatory authorities.
Duties and responsibilities
- >> Perform Data Integrity gap analyses, risk assessments and remediation activities
- >> Lead the implementation of electronic systems to manage quality processes and provide guidance on the computer system validation.
- >> Assist in the maintenance and implementation of the Quality System through the update of the local documentation.
- >> Perform internal and external audits as assigned
- >> Exercise judgment within defined parameters and policies; expected to propose practice and policy improvements.
- >> Act as QA Trainer (GMP training, Quality issues training, new procedures / Policies, …)
- >> Support the site with hosting health authorities and customers inspections
- >> Responsible for other duties and projects as assigned
Qualifications and skills
- >> Master in Sciences or equivalent by experience.
- >> Minimum 3 years of experience in Compliance in a GMP environment.
- >> Previous experience in Data integrity and Computer System Validation projects
- >> Experience in CDMO is an asset.
- >> Ability to work independently in a fast paced multitasking environment.
- >> Rigorous with excellent organization and coordination skills.
- >> Strong customer oriented-mindset.
- >> Flexible, able to set priorities and solution oriented.
- >> Team spirit and ability to work in an interdisciplinary and international environment.
- >> Strong oral & written communication skills (English & French).
- >> Excellent command of Microsoft applications (Word, Excel and PowerPoint)
- >> Working knowledge of SAP, EQMS (TW, LIMS)
What we offer
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
Then we should definitely get to know each other. We look forward to receiving your application via the button Apply or send it to [email protected]