Description
A senior QA / QP is required for a 3 - 6 month contract with a global biopharmaceutical company located in South Holland.The Qualified person will be responsible for the inspection and release of several different products within the company.
Position Specific Tasks:
* Product disposition (Finished Drug Product and Inspected Drug Product)
* Own, review and approve Non-Conformances & CAPA`s, ensuring all procedural and GMP requirements are met.
* Own, review and approve SOP`s and other documentation, ensuring that Corporate, Site and Regulatory requirements are met.
* Perform review and approval of validation documentation.
* Lead and participate in internal and external audits as needed.
* Maintain a close contact and familiarity with company Quality systems and programs utilised at other sites.
* Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
* Act as quality assessor and approver for change requests. Act as a quality representative in change control review board.
* Participate (lead) in various projects and improvement efforts including (new) product launch teams.
* Act as Quality contact in case of regulatory inspections or various questions from regulatory bodies.
* Participate in International Operations Teams, supporting product life cycle management.
* Perform quality agreement approval
* Act as a Recall Coordinator in situation of recall.
* Act as back up for QP roles in other countries if necessary (e.g. Switzerland).
Knowledge:
* Pharmacist Qualification with 3 years of professional experience in pharmaceutical environment
* Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
* Knowledge of the processes involved in clinical and commercial manufacturing, warehousing, supply chain, equipment engineering principles and validation
* Relevant experience in dealing with Quality systems such as Non Conformances, CAPA`s, Change Control, Complaints, Internal and External audits.
* Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGZ, EMA, FDA etc.
Skills:
* Effective communication skills at multiple levels and areas (inside and outside of Quality)
* Thorough decision making skills and ability to apply risk based approach.
* Familiar with risk management tools such as FMEA, etc.
Please apply now for more information!