QA Officer Ii

3 weeks ago


Liverpool, United Kingdom Pharmaron Full time

** Vibrant and dynamic employment - **we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and exciting
- ** Opportunities to develop your skills and yourself - **our rapid growth brings greater opportunities for you to learn and grow faster
- ** A great team where we all support each other - **enjoy your work - after all you spend about a third of your time here

**Requirements**:

- Degree or equivalent in relevant discipline
- Evidence of a high level of proficiency with IT Systems
- Experience in Pharmaceutical Quality systems
- KNOWLEDGE & SKILLS
- Demonstrable ability to follow written procedures and to evaluate systems and records
- Good knowledge of IT systems
- Ability to work to written systems, and a methodical approach to performing duties
- Effective organizational and time management skills
- Excellent attention to detail and a methodical approach
- Willing to get involved with new ideas and initiatives
- Appreciation of need to comply with regulatory requirements
- Willingness to share information and help others
- Excellent communication and interpersonal skills, with the ability to provide support to other teams in meeting the commitment to cGMP and patient safety.
- Some flexibility in working hours
- Helpful attitude, highly motivated team worker

**Key roles and responsibilities**:

- Implement Quality Systems:

- QA Team participation
- Assess own workload and training, and discuss with the Senior Quality Manager, R&D any perceived discrepancy between work assigned and ability to complete it.
- Batch Review and Release facilitation
- Ensure that all data relating to a batch intended for release (including data for raw materials, equipment/consumables preparation, manufacturing records, QC records, non-conformances/deviations) are collated, reviewed by the Production, QC and QA managers and provided to the QP responsible for release of the manufactured material.
- Management of Change
- Participate in the change control procedure to ensure that all changes affecting the GMP areas are controlled to maintain compliance at all times.
- Evaluate trends and compliance levels
- Participate in the evaluation of trends in non-conformances, environmental monitoring data, critical equipment performance and alert the Senior Quality Manager, R&D to any need for re assessment of quality standards. Communicate to the Senior Quality Manager, R&D in an effective manner the compliance status and significant issues. Prepare reports as required detailing key quality performance indicators.
- Audits
- Participate in audit plans and resource requirements, and internal and supplier audit programmes. Prepare audit reports and progress and corrective actions with auditees. Report progress and problems to the Senior Quality Manager, R&D.
- Provide support to the Manufacturing Operations Team
- Support operational activities to ensure that materials and documentation of an appropriate standard are available, and that manufacturing areas and equipment are released for use in a timely manner.
- Provide support to the QC Team
- Support QC activities to ensure that samples and documentation are supplied for testing, reporting and review for incorporation into batch documentation and release procedures.
- Project Support
- Act as QA representative on project teams, ensuring projects are managed in conformance to Quality Policies and procedures.
- Supplier Management
- Manage approval of supplier to ensure compliance with policies to support site projects.
- Validation

Provide support and guidance to ensure that all validation protocols meet requirements, current standards and industry practices. Ensure that all data relating to a validation exercise (including data for equipment/instrument calibration, planned preventative maintenance, exceptions, testing results) are collated correctly and reviewed by the system user / validation. Ensure validation reports reflect the true finding of the validation exercise and that significant issues are communicated to the Senior Quality Manager, R&D in an effective manner.**Our Company**:“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year


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