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QP - Qualified Person - Pharmaceuticals
QP – Qualified Person - Pharmaceuticals
Livingston
Permanent role - highly competitive salary
My client a highly successful international Life Sciences organisation is looking to recruit an experienced Qualified Person / QP - with a Pharmaceuticals / Steriles background.
As a QP, the successful candidate will be responsible for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products. You will also maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, and are operating effectively within UK, EU, FDA, RoW regulatory requirements and standards
The successful candidate will be Qualified under permanent provisions, preferably with biological / biopharma products experience. A biology qualification or equivalent with a minimum of sterile dosage form manufacturing and release experience.
Key responsibilities:-
To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
- To represent the company to external authorities on liaison with MHRA, FDA and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
- To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status, the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
- To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subjected to temperature excursions and communicate to customers
- To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
- To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
- To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
- To prepare and / or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
- In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
- In conjunction with QA to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
- To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
- To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
- In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g. key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
- To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
- Implement and maintain Standard Operating Procedures, as required
Essential Requirements:-
- Qualified Person under permanent provisions – this is essential
- Sterile dosage form experience.
- Experienced in batch manufacturing and release
- Ability to manage conflicting priorities and workloads.
- Ability to work well on own initiative and under pressure, be able to think ‘outside the box’ well as being able to work well with others.
- Biology degree or equivalent.
- Biological product experience would be an advantage
- Previously named on a Manufacturing Importing Authorisation
Skills and Competencies:-
- Proven ability to make confident decisions based upon sound justification
- Proven ability to apply problem solving skills to a wide range of issues while maintaining a positive attitude towards those involved
- Proven ability to manage multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out
- Demonstrable ability to adapt to change and implement change accordingly
In return you will be offered a competitive salary and highly attractive benefits package including bonus and private health care.
On application please advise re current salary package and re expected salary and re any applicable notice period.
Status: Permanent |
Location: Livingston |
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