Work Experience: GlaxoSmithKline, Ware, Hertfordshire (2000 – Present)
Roles held within OSD Production, Operational Quality and Packaging Material Quality Control labs through my 25-year career, which has given me a broad overview of how a pharmaceutical manufacturing site operates.
Role: Operational Quality Co-Ordinator OSD (May 2025 – Current day)
After my secondment finished, I returned to my role within Operational Quality OSD as a Quality Co-Ordinator covering OSD & Micronising. The new tablet manufacturing facility had now opened, where I was trained in new ways of working. Additionally, I continued to provide support to PMQC testing due to constrained resource, demonstrating my flexibility.
Whilst learning the new OSD ways of working, I also created manual CofAs for RSC whilst a new laboratory information system was introduced, as all batches released required manual certificates.
- I transitioned into the role as CofA SME for OSD & was involved heavily with multiple CAPAs for CofA deviations, which resulted in re-creating approximately 100 CofAs from start all the way through to completion.
- I created Linerixibat specific CofAs for 3 CT batches which required creation of a template for CT batches. I PQS (Product Quality Specification) as a guideline to create to the CofA template with all the correct certification statements, regulatory statements, and batch/material details.
- I have created all the SOPs/Wis for CofA Pack creation.
- I am flexible in ways of working to be able to work with NPI state and commercial products
- I use eBRS/MM for batch document review and closure of atypical events.
- I’ve supported operational quality group by reviewing documentation prior to QP certification for OSD eBRS batch documentation & Micronising eBRS batch documentation.
- I’ve been involved in documentation checking of PQ (Performance Qualification) batches & PPQ (Process Performance Qualification) batches for the new tablet facility.
- Updated batch documentation templates & line clearance forms as per required improvement ideas and CAPA.
Role: PMQC Analyst (Secondment Role) (May 2024 – May 2025) (Packaging Material Quality Control)
- Adapted to changes in OSD Quality due to downsizing & NPI transition.
- Expanded knowledge beyond OSD by working in PMQC.
- Ensured quality compliance of packaging materials with regulatory & GMP/GLP standards.
- Learned various testing methods & worked closely with Certificates of Analysis (CofAs).
- Followed strict LAM’s, PMRT’s Drawing Specs, Material specs & Quality specs.
- Became the SME for Glams artwork & specification system.
- Implemented continuous improvements & fresh ideas from a new perspective & previous experience. Devised & implemented idea to ensure safer work conditions, to prevent accident or injury whist working within the dark room.
- Developed strong verbal & written communicational skills with Supply Quality, Pack Tech, contract labs, & international suppliers, through investigations & liaisons due to VI’s & TPI’s.
- Ensured expedited materials got expeditiously tested, including escalating, investigating & remediating spec issues within Harmony & Glams artwork & specification systems to ensure an expedite could get specs confirmed to send out sample for contract lab testing & get PMQC testing performed before micronizing stopped production due to awaiting this.
Role: Operational Quality Co-Ordinator OSD (2020-2024)
Supported operational quality group by reviewing documentation prior to QP certification for OSD & Micronising. I was the first QC trained in micronizing documentation checking.
- Promoted GMP awareness & ensured adherence to quality standards, ALCOA+ principles, & data integrity, through interaction with production staff to discuss errors found & the utilisation of quality advice to compliantly make corrections, or advice for quality issues.
- Functioned as SME & trainer for CofA process, leading multiple CofA projects from start to completion. (e.g. China CofA update)
- Use of Sapphire Labvantage Lab test result recording system.
- Reviewed production equipment logs, production logbooks, & performed regular process confirmations.
- Maintained a system for documentation tracking, batch progression, also for batch documentation error recording for trending.
- Participated in self-inspection activities, GEMBAs & quality improvement initiatives, including preparing detailed documentation/processes introduced into new CofA SOPs & WIs.
- Collaborated with other areas/suppliers to resolve errors & improve processes, ensuring an initiative-taking quality mindset.
- Involvement in deviations from GMP specifications & GSK specific standards. Contributing quality guidance to production, to reporting, ensuring the situation is recorded compliantly, ensuring the deviation could then be created, investigated & remediated.
Role: Manufacturing Technologist OSD (2019 – 2020)
Whilst performing this role I was also still performing shift coordinator duties too
- Operated process equipment across multiple unit operations, ensuring high-quality product output.
- Adhered strictly to GMP, maintaining process & equipment integrity.
- Supported technical troubleshooting & process improvements within GMP guidelines.
- Collaborated with other functions to ensure smooth material and information flow.
- Proficient in problem-solving & process improvement tools.
- Skilled in electronic process systems (SAP, Cdisy, DCS, MVS, MS Office).
- Maintained 5S standards & updated logbooks.
- Reviewed & amended batch documentation, SOPs, & SWIs.
- Collaborated with developing staff on non-standard and first-time manufacturing processes.
- Strong time management, scheduling, & decision-making skills.
- Ensured quality & data integrity, building trust with quality teams.
- In-depth knowledge of GMP, quality, risk, & safety requirements.
Role: Shift Coordinator OSD (2016-2019)
- Ensured smooth & efficient operations, prioritizing customer, safety & needs.
- Managed staff planning, deployment, training, & holiday schedules.
- Functioned as first responder to line alerts & abnormal events affecting product quality & safety.
- Led root cause analysis & problem-solving initiatives, encouraging team involvement & continuous improvement.
- Conducted in-line reviews, Gemba walks, & confirmations.
- Consulted with planning to optimize production schedules & meet targets.
- Supported the Production Team Leader in organizing improvement activities & conducting safety & quality inspections.
- Attended & led TAP meetings in the absence of the Production Team Leader.
- Promoted & ensured safe working practices, following SOPs, SWIs, GMP, & using appropriate PPE.
- Collaborated with quality teams to maintain strict data integrity & quality standards.
- Demonstrated flexibility by working in various production areas & learning new skills.
- Coordinated with planning, technical, engineering, quality, warehouse, management, & Pharm Dev teams.
Role: Manufacturing Operator OSD 2009–2016)
- Fully trained Dispensing & Granulation operator & workplace trainer, Responsible for training new starters /maintaining training activities.
- Ensured lofty standards in manufacturing OSD products, adhering to PPE, SOPs, GMP, & Health & Safety guidelines.
- Developed skills for Shift Coordinator role, including scheduling & communicating downtime.
- Functioned as OSD Safety representative, ensuring safe processes & environments.
- Participated in Continuous Improvement group, implementing safety & quality improvements.
- Collaborated with Quality colleagues to check OSD batch documents.
- Authored & maintained logbooks for OSD.
- Experience of being involved in a FMEA process.
Role: Packaging Line Leader OSD (2007 – 2009)
- Supervised, motivated & lead staff to ensure high-quality product output adhering to GMP & safety standards.
- Focused on performance, attention to detail, waste reduction, schedule adherence, & cycle time reduction.
- Analysed performance data, led meetings, & managed performance issues.
- Ensured accurate technical recordings & compliance with GMP & health & safety policies.
- Utilized SAP/MERPS for daily transactions.
- Verified batch documentation for quality & compliance, ensuring timely submission to QA.
- Assisted in packaging operations to maintain smooth line operations & team morale.
Role: Packaging Operator OSD (2000–2007)
- Operated bottling & blister packaging machines.
- Trained on all lines.
- Conducted thorough line clearance & mechanical changeovers.
- Cleaned lines & product contact parts per GMP guidelines.
- Performed IPC checks to ensure consistent product quality.
- Reported unsafe practices & incidents, raising UIRs (now ZAPs).
- Served as Safety Representative for OSD on the SIG team.
- Experience of being involved in Kaizen events.
