To apply for an advertised position please send your CV together with a covering letter or email stating your salary expectations to the person indicated.
For all recruitment enquiries please contact our HR department 01980 557009, or e-mail firstname.lastname@example.org. Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.
Senior Clinical Quality Assurance Auditor – 2-Year Contract
An excellent opportunity has arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com .
As a Senior Clinical Quality Assurance Auditor within a multi-disciplined company, you will utilise your GCP auditing expertise, regulatory knowledge and excellent communication skills to support the audit programme for the clinical development and pharmacovigilance functions. You will also be expected to plan, conduct and follow-up investigator site audits, process audits, vendor audits and internal and documentation audits, with the auditing occupying about 80% of working time in the UK or abroad. In addition, you will provide support, advice, education and training to other departments involved in GW clinical trials and pharmacovigilance activities, and may also be required to train other members of the Clinical QA team.
You will support GCP and PV regulatory inspections; assist with the set up, review and maintenance of SOPs within Clinical Development and Pharmacovigilance and support the development, maintenance and audit of documentation intended for regulatory submission.
This will be a broad based position, providing exposure to all aspects of drug development and post-marketing data. Reporting to the Clinical QA Manager and based from GW’s Clinical Development office in Histon, Cambridgeshire (for Internal Process and PV audits); at the various audit sites (UK or abroad – for Investigator Site and Vendor audits); and with a degree of home-based working (for Documentation audits and audit report writing / audit preparation), this is a highly interactive role, requiring self-reliance, excellent organisational and communication skills, effective strategic thinking and planning skills, the ability to operate effectively within a busy team, and build influential relationships both internally and externally.
- A Biological Science Degree or Nursing qualification is preferred
- Proven experience in a GCP and/or PV auditing role
- Experience in the conduct of most of the following audit types:- Investigator Site Audits, Vendor audits, Pharmacovigilance audits, Process audits and Documentation audits
- Excellent organisational skills
- Able to work independently or as part of a team
- Good at multi-tasking and working to agreed deadlines.
- Excellent attention to detail with the ability to identify the root cause of problems
- A full driving licence is required along with the ability to travel approximately 50% of the time, both within the UK and overseas.
This is a 2-year Contract Position (40 hours per week), with about 80% of the time spent auditing (internally or externally as per the business needs).
If you believe that you have the skills and drive to succeed in this role, we can offer competitive remuneration and benefits.
Closing Date: 31st July 2013
Quality System Project Lead
Attractive Salary + Benefits, South East England
An excellent opportunity has arisen to work within GW Pharmaceuticals plc, an innovative research-based pharmaceutical company specialising in unique cannabinoid-based medicines. This role not only supports the manufacture of active pharmaceutical ingredients and finished products for commercial, investigational and specials use in a rapidly growing operation across multiple markets but also interacts with the Clinical QA team managing the audit programme for all GW clinical studies. A multi-million pound site expansion project is currently underway.
cGMP Quality System Project Lead
This contract role is for a Quality System Project Lead to manage the project to upgrade the quality system by strengthening and rationalising it to a single company compliance system suitable to take the company forward as it expands.
The Quality System Program Project Stream Lead is accountable for the delivery of the Quality System development project within the constraints of the agreed schedule and budget, through appropriate planning, execution and team management. The program project stream lead ensures the effective performance of all team members under his/her control. The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
As a project lead reporting to the Director of Quality and working closely with the PAI Program Lead, you will be based within the multi-disciplined Quality team you will utilise your extensive GxP knowledge and excellent compliance and communication skills to oversee the quality system upgrade project for GW ’s manufacturing and development function, including the clinical studies programme.
You will also provide support, advice, education and training to other departments and whilst based at GW manufacturing sites there will be crossover between cross-functional areas such as GMP, GCP, GLP, and Computer Systems Validation as the quality system becomes more integrated across sites.
Candidates should have proven management experience in an MHRA/FDA regulated environment, and have an excellent working knowledge of current ICH, EU and US regulatory requirements and their implementation. Experience with non-sterile dosage forms such as oral liquids and capsules, and/or natural products - particularly botanicals - would be advantageous.
Reporting to the Director of Quality and based at the company’s main manufacturing site, this is a highly interactive and influential role, requiring self-reliance, effective strategic thinking and planning skills, leading a busy but well-established and confident team. Excellent leadership, negotiation and influencing skills are absolutely essential, complimenting the strong approach to quality on which GW prides itself.
- Ideally a bioscience degree or chemistry/pharmacy qualification
- Broad experience of GxPs, especially cGMP, GCP and CSV
- Must have worked in a GxP or regulatory environment at management level
- A working knowledge of US FDA cGxP requirements would be advantageous
- Experience of successfully managing a team
- A full clean driving licence is required
If you have the skills and drive to succeed in a dynamic and fast paced environment, we can offer competitive remuneration and career potential.
Process Chemist: Separations and Extractions
GW is looking for an experienced Process Chemist to join its R&D team in Kent. Working as a key part of a small team, the successful candidate will be required to identify and develop processes for the extraction and isolation of novel compounds from plant materials. The novel compounds form part of the Company’s investigative programme and, as such, the work in the department is regulated It is therefore essential that written instructions are carefully followed and actions documented. Experience in Good Manufacturing Practice would be useful.
Experience / Qualifications
To be selected for this position you will have a relevant scientific qualification (degree level) with proven experience in a process chemistry environment, including development and scale up of crystallisation processes and supporting analytical techniques. Experience of extraction / purification processes including preparative HPLC, Supercritical Fluid Chromatography and Supercritical Fluid Extraction would be a definite advantage, but is not essential, as full training will be provided. You must have good communication skills, have basic computer skills (i.e. Microsoft Word and Excel) and be self-motivated. This is an excellent opportunity for anyone interested in furthering their career within the pharmaceutical industry. Salary will be dependent on skills and experience.
Key aspects of the role include:
Process development in the laboratory and through scale-up, especially isolation and purification techniques
- Development of crystallisation processes, including control of crystal form and habit
- Application of Prep-HPLC and SFC for the purification of intermediates and/or Active Pharmaceutical Ingredient (API)
- Extraction techniques, including supercritical fluid extraction (SFE)
- Operate complex production equipment and analytical instrumentation and be able to develop novel and utilise known techniques to prepare defined quality products
- Design and execution of experimental programs.
- Issuing reports from experimental work
- Provide technical support to the manufacturing facilities when necessary
- Supervising and training technical staff when necessary
This is a full time, permanent position, based in Kent.
Closing Date for Applications: 21st June 2013
GW is currently seeking a Program Scheduler to facilitate Project Planning through an exciting multidiscipline project in readiness for regulatory approval for product introduction to the US market. The Program Scheduler will work with cross functional teams to ensure an optimum schedule is maintained.
The Program Scheduler will be required to:
- Work in conjunction with project and program leads to ensure local accountability and responsibility for delivery against plans is maintained whilst facilitating up to date and accurate planning documentation and reporting.
- Work in conjunction with project and program leads to ensure proactive risk identification and mitigation approaches are applied and maintained throughout the program lifecycle.
- Ensure all planning changes are clearly documented and recorded.
- Gather progress information from Project Team members to allow progress to be monitored, and highlight issues/delays to the Program Leads.
- Provide performance measurement.
- Work with project leads to establish, develop and maintain individual plans to track actions, maintain dependencies and identify resource requirements
- Work with project leads to identify potential and actual risks to the success of individual plans.
- Work with project leads to facilitate the resolution of resource or priority conflicts in a constructive and challenging fashion ensuring a pragmatic balance between control and timely delivery and quality.
- Report to the program leadership team on progress against individual plans, identifying resource issues and escalating risk issues for resolution.
- Consolidate the individual project plans into one or more program plans identifying key program milestones, resource needs, issues and risks
- Report to the Pre-Approval Inspection Readiness Leader on progress of project
- Report resource issues to the Pre-Approval Inspection Readiness Leader
- Be responsible for maintaining cGxP and H&S knowledge applicable to the job.
- The successful candidate will have proven ability to apply sound logic when translating information into a logical sequence of events which require fully linked dependencies
- Proficient in project risk and issue management
- Good organisational skills, including the ability to organise the work of a team to meet agreed deadlines; ability to work independently or as part of a team, to agreed deadlines
- Strong analytical and reporting skills
- Excellent computer literate in Microsoft packages.
- Experience of Planning and Scheduling in complex design and development programs is essential. The successful candidate will also be able to understand and work with a technical and skill-diverse team.
Key Attributes and Behaviours:
- Communication & Influence: Communicates verbal and written information in a clear and accurate manner. Adapts communication to the audience and listens effectively to others. Recognises the different views of others and uses persuasive and compelling arguments to influence, and is a good facilitator.
- Change & Innovation: Proposes new ideas and approaches to support continuous improvement.
- Working with others: Takes a co-operative approach to working with others, sharing knowledge and information. Establishes and develops effective and positive professional relationships. Demonstrates a considerate and thoughtful approach to others and contributes to team activities.
- Planning and Organising: Organises time effectively and prioritises tasks according to their urgency and/or importance. Plans work to meet defined objectives and deadlines, whilst building in flexibility and contingencies. Budget management.
- Commitment to Quality & Standards: Demonstrates a focus on achieving results and objectives for the ultimate benefit to the patient. Ensures guidelines and procedures are followed and speaks up about issues of compliance. Achieves high quality standards and accuracy of work completed. Maintains high standards of honesty and integrity.
- Responding to Problems: Identifies and responds to problems in a timely manner. Analyses information effectively. Identifies the root cause(s) of problems and proposes realistic and practical solutions to address them.
- Decision Making: Exercises good judgement in making recommendations, considering all the available sources of information and alternatives. Makes timely decisions with conviction, even in the face of uncertainty or limited information. Takes a pragmatic and practical approach to making decisions.
This is a full-time, fixed term position for 6 months, based in the South East of England.
To apply for any of our roles advertised please send your CV with covering letter and salary expectations to:
GW Pharma Ltd
Porton Down Science Park
or by email to: