We are currently recruiting for a QA Officer - Operations within our QA Team at our Morpeth site.
Job Overview
This role is to support the manufacturing and release processes for API, finished product and packing; and to be the key point of contact for manufacturing for any quality related issues.
Key Responsibilities
* Adhere to internal policies and procedures
* Promote a quality culture across the business
* Ensure product is made in accordance with applicable registered details including but not limited to the site MHRA licenses.
* Review of API, finished drug product and packaging batch documentation prior to QP release
* Review and approval of associated batch documentation, including but not limited to, QC data, cleaning reports, testing reports/records, validation protocols/reports and other associated GMP documentation
* Release of API for internal use and external sales
* Release of bulk drug product for onward internal processing
* Upload of serialization data
* Support and advise manufacturing departments with regards to GMP
* Review and approval of relevant deviations, change controls, CAPA, ALIR’s and other associated quality actions and commitments
* Assist and resolve GMP issues through identification of problem areas and recommendation of CAPA
* Carry out regular GEMBA walks and have on-site presence in manufacturing areas
* Conduct self-inspections and advise on corrective action
* Support MHRA/FDA and other regulatory body inspections, when required
* Support Customer audits, when required
* To proactively support other quality departments, where required
* To carry out other reasonable tasks which are deemed necessary, as instructed by your Line Manager
Key Competencies
* Ability to establish a collaborative working relationship between key stakeholders
* Effective communication skills
* Good analytical and numeracy skills
* Effective influencing and negotiation skills
* Excellent attention to detail
Essential Qualification
University Degree is preferred for this role, but not essential.
Relevant Experience
* Experience in the pharmaceutical industry in a similar role (QA, QC, Regulatory, etc.)
* Excellent knowledge of GxP, including the MHRA’s Orange and Green Guides, EU’s EudraLex Vol. 4, USA’s CFR 210 and 211, along with ISO, ICH, GAMP and PIC/S standards.
* The ability to interpret the above regulations in a pragmatic, risk-based manner.
Job Types: Full-time, Permanent
Additional pay:
* Bonus scheme
Benefits:
* Company pension
* Cycle to work scheme
* Free parking
* Life insurance
* Private medical insurance
* Referral programme
Schedule:
* Day shift
* Monday to Friday
* No weekends
Ability to commute/relocate:
* Morpeth: reliably commute or plan to relocate before starting work (preferred)
Experience:
* QA: 1 year (preferred)
Work authorisation:
* United Kingdom (required)
Work Location: In person
Reference ID: QA Officer - Operations_Aug24
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