Quality Compliance Specialist
- Employer
- Planet Pharma Staffing Limited
- Location
- Buckinghamshire (GB)
- Salary
- Competitive package
- Start date
- 4 Jun 2019
- Closing date
- 4 Jul 2019
View more
- Discipline
- Quality, Auditor, GCP, QA / QC, Systems Manager
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
OBJECTIVE
The role will contribute to the strategic design, implementation and delivery of quality management and quality assurance to the company global and local operational teams as part of the Quality Management department. You will ensure all functions, programs and projects for the company (and all partners) at all locations are working in compliance with the company’s quality standards and written procedures, Health Authority (HA) guidelines and regulations, and local laws. This includes all clinical trials, pharmacovigilance, data management and information technology. Ensure full, compliant documentation is present in collaboration with company functions: Nursing, Pharmacy, Vendor Services, Project Management, Regulatory, Training, HR, IT, Corporate Services and other relevant support functions.
RESPONSIBILITIES:
AUDIT & SYSTEM REVIEW
- Perform regular study reviews (as per the approved schedule) by assessing project files and archives to ensure completeness and compliance with regulations such as GCP, GMP and GDP along with medical and nursing requirements.
- Host and be the point of contact for customer & vendor audits and regulatory inspections.
- Supports stakeholders in preparing for related Health Authority inspections. Assists in Back-room Inspection activities and support including assistance in preparation and responses to Health Authority inspections and customer audits.
TRAINING & KNOWLEDGE MANAGEMENT
- Assists in the development and implementation of effective training programs that support company quality objectives, and in the capture and dissemination of lessons learned.
GOVERNANCE & OVERSIGHT
- Monitoring and communication of audit and inspection findings.
- Collate trend analyses, quality metrics and key performance indicators from the business and report to the Operating Board each month. Report quality trends to division heads on a regular basis.
- Provide advice and support to the operational teams and functional heads as required.
- Ensure project learnings, audit findings and issues are integrated into company Quality Management System (QMS).
- Coordinate and follow-up on audit responses, CAPAs (project, vendor & audit), SOP deviations and maintain log of findings.
- Attend Board sub-group meetings to provide Quality Management updates to functional heads and the Quality Director.
CONTINUOUS / PROCESS RECOMMENDATIONS
- Regular liaison with Director of Continuous Improvement, Training Manager and senior operational managers, the Quality Board sub-group, CEO-Quality meetings and the functional group-quality group meetings.
- Regular liaison with functional heads and Quality Organisation.
- Ensure follow up training is arranged based on audit and review findings.
- Provide input into company change management and continuous improvement systems
ESSENTIAL REQUIREMENTS
- A Bachelor of Science BSc (Hons) 2.2 or above (or equivalent) degree is required.
- Working knowledge of established project management tools.
- At least 2 years experience in operational activities within the pharmaceutical Industry.
- Experience in a clinical research environment with strong working knowledge of ICH-GCP E6 regulations.
- Working knowledge of the drug development process, quality assurance procedures and policies, and quality evaluation techniques.
- Knowledge of the clinical trials regulations, auditing and inspection process.
- Proficient in Microsoft Office applications.
- Confident communication skills both written and verbal, including report writing.
- Pays attention to detail. Process focused. Able to forensically examine documentation for errors and uncover non-compliance.
- Able to work independently and as an effective member of a multidisciplinary team.
- Able to prioritise and schedule workload effectively.
- Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks.
- Excellent English both verbal and written.
LOCATION
Office based in Buckinghamshire (may offer some flexibility to work from home)
DURATION
Permanent / full-time
SALARY
Competitive salary plus benefits
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
TO APPLY
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on schapple@planet-pharma.co.uk
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
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