Emma Pickard

Personal Statement

I am a highly motivated individual; I enjoy working as part of a team & individually to reach goals in a methodical & logical manner whilst maintaining high attention to detail. With my extensive experience within the pharmaceutical industry & my passion for ensuring excellence through quality control, I am confident in my ability to contribute to the success of your team. I am initiative-taking & thrive in challenging environments, where my elevated levels of diligence allow me to consistently deliver exceptional results.

Key Skills

• Operational Quality subject matter expert (SME) for the creation and update of Certificates of Analysis for released batches in Oral Solid Dose (OSD), Micronising and Respiratory (RSC).
• Exceptional knowledge & understanding of the importance of Quality & data integrity.
• Formal root causing & problem-solving techniques through RCA’s & Investigating local deviations & implementing the corrective & preventative actions.
• Ability to organize & prioritise workload, always ensuring elevated levels of attention to detail.
• Actively promotes a safe working environment.
• Understands Health & Safety & GMP requirements.
• Experience leading improvement activities through 5S & Continuous Improvement.
• Proven Coaching & Training experience.
• Expert competency in standard work.
• Able to work in an ever-changing environment.

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.

Qualifications

• Presdales School for Girls, (1992-1997) - 10 G.C.S.E.’s.
• North Herts College (1997 – 1999) - BTEC National Certificate in Sport Science.

Hobbies

• Powerlifting within the WRPF
• Individually competed Nationally & Internationally for Great Britain Wakeboard Team.
• Eight times UK National Wakeboard Champion.
• 2019 European & Africa Wakeboard Champion.
• Gym Strength training.
• Aggressive Skate Park Roller-skating.
• Previous Ice Hockey Player in Premier League Women’s Ice Hockey Teams & England/ England South Ice Hockey Teams.