Senior QA Officer

Curium Pharma; Oxford; Sur place; GBP 40 000 - 65 000; Plein temps

Résumé du poste

Curium in Oxford is seeking a quality assurance professional to ensure site compliance with the Specials guidelines, the current international pharmaceutical legislation and related guidelines, along with company requirements.

Location: Oxford. You will review GMP compliance of production and analytical methods, manage documentation, assist with deviations, CAPA, OOS and change controls, and support regulatory inspections to maintain a robust QMS.

Qualifications

• Knowledge of radiation (Desirable)
• Strategic thinker, able to see long term opportunities
• Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology
• 2 Years Quality Systems Experience (Essential)
• Experience in the operation of GMP facilities (Essential)
• Sound knowledge of general management practices and business
• High technical aptitude as well as good communicative and interpersonal skills
• Stress handling
• Excellent and up to date working knowledge of current EU GMP

Responsabilités

• Review GMP compliance of production and analytical methods with GMP/Specials guidelines and EP, BP and/or SmPC
• Documentation management including review and update SOPs and forms
• Assist with deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
• Review QC tests and Micro results, managing Out of specification results
• Ensure timely completion and update of all Quality records and trackers
• Support the site to ensure it is GMP compliant by making sure SOPs are up to date
• Oversight, review and Approval of Validation Reports for all equipment in accordance to VMP
• Ensure QMS working effectively and always up to date
• Assist with all elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
• Assist in Quality Management Review data and presentation. Participate in Batch review to aid Release for Shipment and prepare batch manufacturing records for QP review and release in accordance to licence
• Ensure batch records are reviewed in line with licence dossier.
• Audits & Compliance - Assist with inspection readiness
• Collaborating with Head of Quality in gathering necessary data and information for responses to regulatory inspection reports and assuring proposed actions are implemented and completed in a timely manner
• Coordinating internal self-inspections according to schedule
• Take part in Regulatory inspections if required
• Accurately perform Quality Control testing on all manufactured products at the LRP according to SmPC and EP guidelines
• Manage Environmental Monitoring process and ensure data are recorded and trended in the QMS
• Reading Microbiological plates, broth and sterility samples
• Interpretation and recording of Microbiological data and report any out of specifications ensuring appropriate action is taken in a timely manner
• Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy - QA, QC and micro activities must be accurate and maintained at all times
• Assist with preparation of Quality assurance meetings
• Undertake activities as directed by Quality Management

Connaissances

Radiation knowledge

Strategic thinking

Quality systems

GMP experience

Communication skills

Stress management

Interpersonal skills

Formation

Degree in Pharmacy/Chemistry/Biology

Description du poste

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Location: Oxford, United Kingdom, OX3 7JU

Company: curium

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

Ensure site compliance with the Specials guidelines, the current international pharmaceutical legislation and related guidelines, along with company requirements.
Support culture of excellence for the site.

Location: Oxford

Essential Functions

• Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC
• Documentation management including review and update SOPs and forms
• Assist with deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
• Review QC tests and Micro results, managing Out of specification results
• Ensure timely completion and update of all Quality records and trackers
• Support the site to ensure it is GMP complaint by making sure SOPs are up to date
• Oversight, review and Approval of Validation Reports for all equipment in accordance to VMP.
• Ensure QMS working effectively and always up to date
• Assist with all elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
• Assist in Quality Management Review data and presentation. Participate in Batch review to aid Release for Shipment and prepare batch manufacturing records for QP review and release in accordance to licence
• Ensure batch records are reviewed in line with licence dossier.
• Audits & Compliance - Assist with inspection readiness
• Collaborating with Head of Quality in gathering necessary data and information for responses to regulatory inspection reports and assuring proposed actions are implemented and completed in a timely manner
• Coordinating internal self-inspections according to schedule
• Take part in Regulatory inspections if required
• Accurately perform Quality Control testing on all manufactured products at the LRP according to SmPC and EP guidelines
• Manage Environmental Monitoring process and ensure data are recorded and trended in the QMS
• Reading Microbiological plates, broth and sterility samples
• Interpretation and recording of Microbiological data and report any out of specifications ensuring appropriate action is taken in a timely manner
• Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy - QA, QC and micro activities must be accurate and maintained at all times
• Assist with preparation of Quality assurance meetings
• Undertake activities as directed by Quality Management

Requirements

Level of professional and intellectual ability

• Knowledge of radiation (Desirable)
• Strategic thinker, able to see long term opportunities

Education/experience

• Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology
• 2 Years Quality Systems Experience (Essential)
• Experience in the operation of GMP facilities (Essential)
• Sound knowledge of general management practices and business
• High technical aptitude as well as good communicative and interpersonal skills
• Stress handling
• Excellent and up to date working knowledge of current EU GMP

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality. All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Disability Confident Employer

We are proud to be a Disability Confident Level 1 employer and are committed to fostering an inclusive workplace where everyone can thrive. We welcome applications from candidates of all backgrounds, including people with disabilities.