About Kent Pharmaceuticals
Kent manufactures and distributes speciality off-patent/generic pharmaceuticals across the UK, Ireland, and international markets
The business is a UK market leader in several niche products selling primarily to the hospital and pharmacy wholesaler channels
Our portfolio of products is diversified across multiple therapeutic areas, with strengths in analgesics and anti-infectives.
Kent's portfolio contains mainly niche, value-added products, which are complex to manufacture
With a strong pipeline of new product development Kent continues to grow in each of our key areas
The Person
The person should have good health and social behaviour to be able to work in team.
Strong understanding of cGMP, GLP, ALCOA+, and data integrity principles.
Should have knowledge and skill in usage of computer, Microsoft Office, and general documentation.
The person should be team worker, having good communication skills
Purpose of Role
The QC Compliance Officer ensures that all Quality Control (QC) operations in facility comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory requirements.
The role includes oversight of laboratory documentation, investigations, compliance trending, product quality review (PQR/PQRS) support, and water quality monitoring trends.
The position is critical in maintaining the integrity of analytical data.
Efficiency Improvement and lean documentation practices is a key objective within this role.
There may be a requirement to work beyond normal hours to meet the company needs from time to time.
Principal duties and responsibilities
Ensure all QC activities comply with cGMP, GLP, and site SOPs specific to beta-lactam operations.
Monitor compliance with good documentation practices (GDP) and laboratory discipline.
Control & govern the compliance of QC QMS documents and spreadsheets for site.
Issue and approval of QC worksheets(QAR) for RM & FPS testing.
Review and approval of QC worksheets(QAR) for RM & FPS testing.
Oversee the accuracy and completeness of data in QARs, CDS (e.g., Empower), and other QC systems.
Lead or support investigations for deviations, OOS, OOT, and incidents, ensuring timely root cause identification.
Perform trend analysis of analytical results, including stability studies, in-process testing, and finished product release data.
Prepare water system quality trends (microbial, TOC, conductivity, and endotoxin data) and identify any excursions or adverse patterns.
Support the preparation and review of Product Quality Review Summaries (PQRS) or Annual Product Quality Reviews (APQR).
Compile QC analytical data, trend summaries, and stability results for inclusion in PQRS.
Review and approve QC-related change controls impacting test methods, instruments, or procedures.
Draft, review, and revise SOPs, ensuring updates reflect current regulatory and beta-lactam containment requirements.
Collaborate with QA, Production, Engineering, EHS, and Validation teams for compliance alignment.
Participate in risk assessments related to laboratory operations and beta-lactam containment.
Support technology transfer, new product introduction, and process validation activities with analytical data compliance oversight.
Testing, review, and approval of packaging/ raw material components for use in manufacturing as required.
Maintain regular consistent and professional attendance, punctuality and personal appearance and adhere to relevant GMP and Health & Safety procedures.
Maintain good housekeeping practices as per GMP
Managing qualification and calibrations of laboratory equipment through liaising with various service providers for laboratory equipment.
Transfer of key systems to eQMS platform
Drive efficiencies via generation of SMART document trackers, master lists, eliminating duplication of same and transcription duplication.
Efficient and accurate control & archiving of QC QMS documents for easy retrieval.
Skills and Experience (E: Essential, D: Desirable)
Proficient in Microsoft Excel/ PowerPoint & Word (E)
Strong understanding of cGMP, GLP, ALCOA+, and data integrity principles.
(D)
Sound knowledge of regulatory guidelines (D)
Having good documentation and office organisation skill (E)
Understanding of quality systems (D)
Effective communication, coordination, and training abilities.
(E)
Education
High school diploma or degree with Sciences subjects
Other Requirements
Valid passport/visa/approvals to work in Ireland
Package
Annual Salary Review (discretionary)
Job Types: Full-time, Permanent
Pay: €35,****** per year
Benefits:
On-site parking
Sick pay
Work Location: In person