Catherine Conway Email & Phone Number

Ireland

Galway, Connacht, Ireland

A highly motivated, dedicated, senior Quality professional with 20+ years proven experience in the pharmaceutical industry. Extensive experience in managing a high throughput laboratory with significant focus on People Management, Quality, R&D, Compliance, Right First Time, Operational Excellence and Regulatory agency audits in support of world wide commercial markets.

QC LABORATORY MANAGER: November 2006 - April 2018Overall responsibility for Finished product, Raw Materials, Packaging, QC Sampling, Stability, Training and Documentation management groups. (headcount of 42, with 4 direct reports)Key ResponsibilitiesResponsible for management of employee relations, change management, policy implementation, motivation, performance, discipline, appraisals, target setting, communications, and trainingDirected the resources of the… Show more QC LABORATORY MANAGER: November 2006 - April 2018Overall responsibility for Finished product, Raw Materials, Packaging, QC Sampling, Stability, Training and Documentation management groups. (headcount of 42, with 4 direct reports)Key ResponsibilitiesResponsible for management of employee relations, change management, policy implementation, motivation, performance, discipline, appraisals, target setting, communications, and trainingDirected the resources of the department to ensure ability to be responsive to the changing needs of the businessLed the Laboratory elements of Regulatory and client audits, i.e. HPRA, US FDA, Chinese FDA, Korean FDA, Brazil, Argentina, Saudi Arabia, Iraq.Worked closely with the commercial and development sections of the business to optimise collaboration ensuring that the demands of all internal customers were fulfilled. Managed this through enhanced communication and knowledge sharing between the relevant business units.Oversaw the introduction of “Lean Lab” which resulted in a significant improvement in the scheduling and output figures from the laboratory and improved resource planning / management. Represented QC on site-wide, senior cross functional project teams that oversaw the transfer of several new products into the site, from initial concept through to commercial approved material i.e. raw material identification and method validation, finished product method validation, process validation level testing.Green Belt qualified, using DMAIC tools for projects and RCATrained to Master Black level in StatisticsTrained in 6SImplemented the current format of RCA analysis used on siteRepresentative on many teams on site in support of Operational Excellence, Laboratory Automation, Great Place to Work, 5S.Coordinated the introduction of Trackwise for investigation management to the QC group Show less

Athlone

Selected to form part of a site OE team for a 12-month secondment position with a goal of identifying and implementing specific cost reduction initiatives. Led various cross functional teams to support cost saving projects using DMAIC approach. Overall team savings of $3 million were identified with $1 million achieved in first 12-months. Presented to the company CEO, delivered regular project updates to the company CFO and site General Manager and senior leadership… Show more Selected to form part of a site OE team for a 12-month secondment position with a goal of identifying and implementing specific cost reduction initiatives. Led various cross functional teams to support cost saving projects using DMAIC approach. Overall team savings of $3 million were identified with $1 million achieved in first 12-months. Presented to the company CEO, delivered regular project updates to the company CFO and site General Manager and senior leadership team.During this secondment position I also retained responsibility for the QC managers role. Show less

Athlone

QC STABILITY SUPERVISOR: January 2003 – October 2006Key ResponsibilitiesCoordinated the consolidation of the development and commercial stability groups into one functional unit involving harmonisation of procedures and group management. Created new template reports to reflect this new group.Liaised directly with clients on all product related activities Represented the group directly with Regulatory and client auditorsManagement responsibilities for the analysts in the… Show more QC STABILITY SUPERVISOR: January 2003 – October 2006Key ResponsibilitiesCoordinated the consolidation of the development and commercial stability groups into one functional unit involving harmonisation of procedures and group management. Created new template reports to reflect this new group.Liaised directly with clients on all product related activities Represented the group directly with Regulatory and client auditorsManagement responsibilities for the analysts in the stability group Approval for SOPs, stability protocols and Change controlsResponsible for management of the warehouse of stability cabinets and walk-in environmental roomsResponsible for generating reports to support Regulatory submissions Show less

Athlone

Key ResponsibilitiesScheduled daily activities, conducted training and mentoring of junior personnel.Generation of reports to support Regulatory filingsTravel to the US site to support controlled substance stability study initiation.Responsible for approval of investigations, calibrations, management of projects and was also a site subject matter expert for HPLC Millennium software (now Empower)

Athlone

R&D STABILITY ANALYST Key Responsibilities / Achievements:Laboratory analysis of in-process and finished product (Solid Dosage Forms / Suspensions) using the following main techniques: HPLC, GC, Dissolution (UV and HPLC), Moisture analysis, Particle size, UV, FTIR to support development programmes and Regulatory filingsReview of analytical data and generation of reports.Collaborated with Method Development, Formulations, QA, QC and Manufacturing groups.

Chemistry, Chemistry / Analytical Chemsitry, Honours Degree

Diploma In Fine Chemicals / Pharmaceuticals, Analytical Chemistry, Distinction

Activities and Societies: Member of the volleyball club, won 3 All Ireland HESF titles while in college with the then Galway RTC