Posted in Industry News, News
If so contact CK Science today! We currently have a number of junior and senior level QA roles based in London, Hertfordshire and Bedfordshire, such as:
- QA Officers
- QA Execs
- QA Managers
- QA Auditors
- QA Validation experts
- Qualified Person (QP)
So if you have experience in QA area and some of the following skills:
- Batch review
- Continuous improvement
- ISO: 9001
- ISO: 13485
- ISO 17025
- Medical Device Directive MDD
- In Vitro diagnostics directive IVDD
- IQ, OQ, PQ
- GMP, GLP
WIth a background in either pharma, biotech, chemical or med devices/diagnostics then call us on 01438 723 500 or click here to search our QA jobs
Posted in Industry News, Jobs, News
Reena Dhana at CK Science is currently recruiting for a TrackWise Systems Quality Associate to join one of the world’s leading research-based pharmaceutical companies based in Hertfordshire on a full time, 12 month fixed term contract.
We are searching for a candidate to ensure an Electronic TrackWise Quality Management System (QMS) and associated systems used for the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and corporate expectations. They will provide input to the review and writing of any associated quality policies, systems and procedures and support the generation of routine status and performance reports covering aspects of Electronic TrackWise QMS.
As a TrackWise Systems Quality Associate you will:
- Support the ongoing operation, maintenance and implementation of improvements to TrackWise processes and systems to meet company needs.
- Support the company Training Management System.
- Maintain copies of Corporate Policies, Guideline, Standards and Procedures.
- Write and review all SOPs associated with the Electronic TrackWise QMS
- Coordinate the Company SOP System.
- Coordinate the internal and external audit process, audit schedules and the associated audit files.
- Participate in Audits
- Coordinate and support GMP Training.
- Provide day to day support to other members of the TrackWise Systems team, as appropriate.
- Support the reporting of Quality Operations and company Key Performance Indicators
- Perform appropriate duties at the request of the Senior TrackWise Systems Associate
- Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
The successful Track Wise Systems Quality Associate will have the following qualifications, skills & experiences:
- Able to maintain working relationship and communication links within the company, affiliated organisations and third party contractors as appropriate.
- Knowledge and experience of Quality Assurance, Quality Systems, GMP and a basic understanding of manufacture and packaging of pharmaceutical products.
- Technical and scientific judgement.
- Self motivating individual comfortable working with detailed information and data.
- Good communication skills.
- Developed presentation skills.
- Computer literate e.g. Word, Excel and PowerPoint.
- Able to follow defined processes and procedures.
If successful, you will join a company that truly values it’s employees and is completely focused on the patient. In return there is an attractive salary, coupled with excellent benefits and extensive training/career progression opportunities.
How to apply:
To apply for this TrackWise Systems Quality Associate position please contact Reena Dhana via email: email@example.com or telephone: 01438 723 500. Please quote reference ST26527 in all correspondence.
Posted in Jobs, News
Jason Johal at CK Science is currently recruiting for a QA Service Provider Strategy Lead to join one of the world’s leading research-focused healthcare groups for at their Hertfordshire site on a full time, permanent basis.
This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.
Joining the international Product Development Quality Assurance (PDQA) team, this position will be assigned to the Laboratory service category (GLP, GCP). Reporting to the Principal Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level.
As QA Service Provider Strategy Lead you will:
- Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
- Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
- Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur.
- Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas.
- Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary
- Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks
- Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
- Support regulatory authority GCP inspections at service providers
The successful QA Service Provider Strategy Lead will have the following qualifications, skills & experiences:
- Bachelor’s degree or equivalent in a scientific or quality related field or equivalent combination of education, training and experience
- Extensive experience in the pharmaceutical industry and/or quality assurance with excellent knowledge of a GLP or Pharmacovigilance Service Provider Quality role
- Demonstrated knowledge of GLP, GCP, CSV, PV / drug safety and regulatory requirements
- Project management experience with proven leadership, mentoring and coaching skills
- Experience supporting Service Provider sourcing initiatives and/or representing QA on Service Provider Strategic Alliance or Category governance teams
- Proficiency in the conduct of GxP related audits of Service Providers
- Experience supporting regulatory authority inspections
If successful, you will be joining a QA Service Provider Strategy Lead. In return there is:
- Attractive salary
- Excellent benefits
- Career progression opportunities
How to apply
Apply online now
To apply for this QA Service Provider Strategy Lead position contact Jason Johal via email: firstname.lastname@example.org or telephone: 01438 723 500. Please quote reference ST25997 in all correspondence. Entitlement to work in the EEA is essential.
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Posted in Jobs, News
Reena Dhana is currently recruiting for a Quality Assurance Auditor to be based within the GMP quality department of a global pharmaceutical company who are based in Hertfordshire. This is initially a temporary contract of 4 months with a strong possibility of extension.
As a Quality Assurance Auditor you will ensure compliance to cGMP of all activities related to the development of pharmaceutical products for use in Clinical Trials, including the Quality Management systems and you will carry out Quality compliance reviews/release of Investigational Medicinal Products for use in Clinical Trials. Other duties will include:
- Auditing and approving procedures and documents from manufacturing
- Analytical, packaging and service groups
- Reviewing and approving equipment and facilities qualification
- Training others as appropriate
- Assisting with external audits as required.
The ideal candidate for this Quality Assurance Auditor role will hold a BSc in a Life Science subject (or equivalent) and will have experience gained within relevant departments of Pharmaceutical companies, preferably Quality Assurance. You will have a good working knowledge of cGMPs. An understanding of Clinical Supplies requirements would be advantageous.
How to apply:
For more information or to apply for this Quality Assurance Auditor role please contact Reena Dhana on 01438 723 500 or email email@example.com. Please quote reference ST23319 in all correspondence.