Are you looking for an opportunity to perform Qualified Person (QP) responsibilities and ensure regulatory compliance?
Do you want to be responsible for the timely progression of Cell and Gene Therapy products?
Are you located in Amsterdam, The Netherlands, or are you willing to relocate?
Fraser Dove International is partnering exclusively with an established organisation specialising in producing drugs and therapies that target cancer. Operating worldwide, their mission is to improve patient outcomes by killing tumour cells.
Our client is seeking an experienced executive to take responsibility for the batch release of commercial and clinical products.
Discover more about our Qualified Person opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Qualified Person, you will be measured against the following objectives:
1) Fulfilling QP responsibilities concerning the batch release of Large and Small Molecule products.
2) Managing the validation of Large and Small Molecules and Cell Assays.
3) Performing the QP responsibilities to ensure compliance with GxPs, company guidelines and national regulations.
What you will do:
As the Qualified Person, your duties and responsibilities will include:
- Ensuring that each batch has been manufactured and tested following current Good Manufacturing Practice (cGMP).
- Verifying that each batch of the medicinal products are distributed under conditions that meet the Good Distribution Practice (GDP) guidelines.
- Releasing or rejecting unlabelled Drug Products and Finished Drug Products.
- Maintaining or registering a record of product batches certified by the Qualified Person before release.
- Ensuring that the expiry date aligns with the approved shelf life.
- Providing support to improvements of the Quality documentation system to ensure it remains current.
- Providing QP support and ensure the appropriate cGMP and/or study documents, deviations, change control, CAPA etc. have been approved.
- Participating in risk assessment, decision-making, communication, and risk-reducing action related to defective products.
- Assisting in regulatory or other inspections.
What you will bring:
These are the skills and experience you will need to succeed as the Qualified Person:
- A hands-on individual who enjoys challenges and is dedicated to getting the job done.
- Fast-learner, adaptable and excellent communication skills.
- A self-motivated and accountable individual prepared to fix any issues that arise.
- Strong knowledge of GMP and other applicable regulatory requirements.
- In-depth knowledge and experience with quality systems, corrective action, process control, risk management, FMEA and other key tools.
- At least two years of previous experience in a pharmaceutical setting.
- Bachelor’s degree in pharmacy, medicine, chemistry, technology, biology or equivalent.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Car allowance.
- 8% holiday allowance.
Got what it takes?
To apply for the Qualified Person, click the ‘Apply’ button below or contact the Executive Search Consultant – Jason Cachia – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.