Qualified Person

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Qualified Person Location: Home Counties Salary: Negotiable/dependent on experience Duration: Permanent An exciting opportunity to join a Global Biologics company who are recruiting a fully certified Qualified Person as per (2001/83/EC) to be named on their licence and have responsibility of releasing product batches across the UK, Europe and Emerging Markets. You will also manage the QMS team, the design, ongoing maintenance and development of the QMS and act as the GMP Subject Matter Expert as well as work closely with the Senior QA Leadership to recommend process improvements across the entire QA department. Responsibilities (to include, but not limited to): *Undertake the duties of a Qualified Person as defined in Directives 2001/20/EC *Act as point of contact for queries relating to QP certification and batch release. *Ensure that all processes and procedures that are required for QP Certification/batch release of drug substances are fit for purpose. *Provide QA support to initiate, manage and escalate major and critical compliance issues through the site QMS. *Actively suggest, initiate, participate and contribute to QMS process improvement initiatives and projects. *Continually develop, mentor, train and enforce a site GMP culture. *Identify opportunities for GMP compliance training and awareness campaigns and then design, develop and deliver training sessions where required. *Design the system such that both management and QPs have continuous information regarding the performance of both products and quality processes. *Prepare, update, review and approve technical agreements to regulate distribution of pharmaceutical responsibilities across the organisation. Experience required: *Life Science degree (ideally in Biology, Chemistry or Pharmacy) at Bachelor's level preferably supported by PhD, MSc or MBA. *Qualified Person as per 2001/83/EC. *Minimum of 3 years' experience in batch release, CAPA investigations and deviations handling for a variety of dosage forms. Experience desired: *Auditing experience - EU cGMDP/ICH Q7A/ISO9001/PS9001/ISO13485. *Experience in the design and management of a quality system. *Line management experience (Preferred). *Experienced in hosting regulatory authority inspections. *Thorough knowledge and extensive experience of EU cGMDP, Regulatory Affairs, QMS, handling Change Controls, CAPAs, Deviations, Complaints, Complaint Investigations and (both manual and software-based) documentation systems. If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place. Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion. Qualified person, GXP, GMP, GDP, Qualified Person, 2001/83/EC, Audit, Auditor, R&D, Generics, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties,

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