Marta Golec (Piechowska)

Duties:
- To support Product Development and Clinical Supply by ensuring that all project plans and milestones are delivered on time and in full (OSD and FF products)
- To ensure that all analytical methods are developed and validated in accordance with regulatory requirements.
- To ensure all raw materials and finished products are tested to agreed schedules managing the analytical work within the team of 5 (4 analysts, 1 data reviewer)
- To actively plan each new development project in conjunction with the Analytical Services Manager and relevant Project Manager ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
- To determine tasks and resources in conjunction with the Analytical Services Manager required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
- To proactively build effective working relationships with core team and functional members.
- To attend project review meetings and to provide project plan information to clarify situations before deciding a way forward taking all the facts on board.
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines.
- To ensure high quality output by watching over job processes, tasks, work products and documentation to ensure freedom from errors, omissions, defects or data integrity issues in order to achieve a high level of customer service and cGMP.
- To initiate action to correct quality/schedule problems or notify others of quality issues as appropriate.
- To lead Laboratory investigations (Deviations, Out of Specifications, Out of Trends, Change controls, etc.)
- To assist in the preparation for customer /regulatory inspections.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- To troubleshoot, develop, transfer and validate robust, sound analytical methods.
- To prepare or review test methods, protocols and reports (validations, transfers, qualifications, investigation reports, design of experiment reports, method verifications, SOPs and WIs, shelf life justification reports).
- To prepare Submission Documentation in support of licence applications.
- To manage day to day scheduling of laboratory activities.
- To ensure that all raw materials, in process samples and finished products are released in a timely and efficient manner and ensure quality and efficacy of the product.

Duties:
- To manage the analytical work within the team of 19 (14 analysts, 3 data reviewers, stability coordinator and laboratory technician)
- To coordinate between the laboratory work and Client timelines
- To adjust schedules to the Client’s needs on a daily basis
- To coordinate a wide range of the testing within the solid dosages (release testing, stability testing, method transfers, method validations, method optimisations, method development)
- To perform investigations of the non-conformity results, evaluating deviation and client complaints
- To coordinate method development and method validation projects
- To coordinate analytical method transfers
- To ensure stability samples are tested within the required time frames
- To create and review any supporting documentation related to the development, validation and transfer work (development reports, method validation protocols and reports, method transfer protocols and reports)
- To review of the work performed by the analysts
- To perform internal audits within the department
- To generate and keep track of quality metrics for the team
- To troubleshoot and optimise analytical methods
- To generate monthly reports on the financial profits of the team
- To keep track on the revenue and forecast for each month making sure that the monthly targets are achieved
- To actively plan for the team (yearly schedules) and update it on a quarterly basis
- To act as a key contact between laboratory and the Client
- To participat in the Client calls on a weekly basis (on-going testing, project discussions, Client’s requests)
- To support any external audits (FDA, HPRA, Client audits)
- To generate and review SOPs and Work Instructions
- Continuous improvements introduction within laboratory
- To perform mid-year reviews and assign goals to the team members
- Sample authorisation (last step before QA release) in LIMS System
- Collaboration with other departments (Metrology, QA, Client Services)
- EMPOWER administration within the team

Duties:
- To schedule analytical work within the team ensuring all deadlines are met
- To supervise developing, optimizing and validation of analytical methods (UV-Vis, HPLC, UPLC)
- To plan and schedule bulk stability testing (UV-Vis, HPLC, GC, physical testing)
- To troubleshoot analytical methods (supervising of investigations for problematic methods)
- To schedule and coordinate of all analytical investigations (OOS, OOT results) within the team (Trackwise)
- To collaborate with other departments (QC, QA, Manufacturing, Packing)
- To prepare a various types of documentation related to analytical work (specifications, certificates, test methods, validation protocols and reports, method optimisation reports, method troubleshooting reports, stability protocols and reports)
- Analytical data review and approval
- To plan, direct and implement improvements in quality system
- Experienced in writing of standard analytical procedures, GLP and GMP rules
- Empower 2 administrator

- rozwój, walidacja oraz transfery metod AQUITY H-Class UPLC, HPLC, UV-Vis, GC
- obsługa sprzętu i wykonywanie analiz H-Class UPLC, HPLC, UV-Vis, GC, fizykochemicznych
- administrowanie systemów HPLC
- tworzenie arkuszy obliczeń w oprogramowaniu HPLC
- tworzenie dokumentacji związanej z:
* rozwojem metod analitycznych (protokoły oraz raporty walidacji, metody, specyfikacje)
* procesem produkcji leku (certyfikaty, raporty z procesu walidacji, protokoły i raporty stabilności, karty stabilności)
* procesem transferu metod analitycznych (protokoły i raporty z transferu)
- znajomość GLP, GMP
- wprowadzanie Standardowych Procedur Operacyjnych

rozwój i walidacja metod HPLC
- obsługa sprzętu i wykonywanie analiz HPLC
- tworzenie dokumentacji związanej z rozwojem metod analitycznych (protokoły oraz raporty walidacyjne, metody, specyfikacje, certyfikaty)
- znajomość GLP, GMP, Standardowych Procedur Operacyjnych

dwudniowe szkolenie (1 dzień wykładowy + 1 dzień warsztatów) z zakresu walidacji metod analitycznych według normy 17025 oraz przewodnika EURACHEM, omówienie krok po kroku etapów walidacji metod instrumentalnych, metod statystycznych wykorzystywanych podczas wyznaczania parametrów walidacji, ćwiczenia praktyczne na danych surowych