Quality Assurance Project Management

Slawomir Kowalczyk

****, ** **., ******** *** *L* Quebec, Canada,•Ph: 514-***-****, email: *******@*******.***

PROFILE

Dedicated and detail-oriented quality assurance chemistry professional with over 10 years of experience in the pharmaceutical industry in positions of increasing responsibility.

• Work independently to carry out a variety of laboratory, scientific and administrative assignments.

• Experienced in a wide and varied range of statistical and analytical chemistry techniques

• Implemented a variety of laboratory and manufacturing improvements.

• Demonstrated commitment to the safety, integrity, strength, purity and quality of drug products.

AREAS OF EXPERTISE

• Quality assurance

• Investigation of quality incidents

• Knowledge and experience with regulatory requirements including FDA (GMP, GLP) and compendial (USP, JP, BP, EP)

• Experience working with LIMS and other documentation systems

• Strong leadership skills

• Training of team members

• Auditing

• Operational management, development and planning

• PAT incentives

• Chemical laboratory techniques (Chromatography, ICP, AA, UV-vis, FT-IR, near IR, Raman, pH, Melting Point, Distillation, X-ray, Conductivity, Lipid analysis (fat and fixed oil), Karl Fischer, Microscopy, DCS, Particle size analysis, Titrations (manual, potentiometric), TLC, DVS, wet chemistry)

WORK EXPERIENCE

Pfizer 2010- 2011

Clinical Supply GMP Analytic

Scientist II

• Implementation of Pfizer quality assurance program in the laboratory and in clinical supply manufacturing, working in multidisciplinary teams.

• Actively involved in the transition/integration process from legacy Wyeth to Pfizer (SOP, Procedures, ELN).

• Actively involved in method transfer and preparation of regulatory supporting documents concerning transfer from Legacy Wyeth to Pfizer activities.

• Performed release/stability testing on Drug Product.

• Performed raw materials release testing.

• Implemented process analytical technology (PAT) in the Clinical Supply GMP group.

Wyeth Pharmaceuticals 2006-2010

Research and Development, AQS Montreal

Scientist II

• In-depth experience in analytical chemistry, method development, optimization and validation, instrument troubleshooting and maintenance, data analysis and sample preparation to support clinical supply manufacturing and pre-clinical studies.

• Activities include scheduling, testing, reporting, LIMS, checking and trending of data

• Solid experience in initiating and facilitating quality incidents (Quality Incidents, Laboratory Investigations)

• Orchestrated the activities of a multi-disciplinary team to implement process analytical technologies (PAT) in the laboratory and production area that facilitated and increased productivity and efficiency.

• Identified, monitored and mitigated process risks, optimized and developed novel or improved existing processes and established quality standards of raw materials, drug intermediates and finished product.

• Conducted pre-formulation studies

• Performed raw materials release testing.

• Trained personnel on methods, procedures, instrument control and data analysis in accordance with GMP requirements.

• Utilized various analytical chemistry techniques to ensure API and excipients met compendial and internal release requirements in accordance with GMP requirement to support clinical supply manufacturing.

• Managed Lifecycle of GMP quality instruments. Prepared, coordinated and executed validation/qualification protocols for GMP analytical instruments; performed maintenance and periodical review of GMP qualified analytical instruments.

• Provided guidance, coaching and career development support for work associates.

• Provided technical support in problem-solving.

• Participated in the preparation of inspections by regulatory bodies.

• Followed-up on observations of regulatory inspections.

Wyeth Pharmaceuticals 2001-2006

Rouses Point, NY

Quality Control Scientist II

• Troubleshooted investigated and resolved instrument malfunctions and methodology problems.

• Investigated production problems.

• Performed chemical assays of commercial product raw materials, production intermediate and bulk samples, finished product and validation samples.

• Performed various physical tests on packaging components.

• Trained and mentored laboratory personnel.

• Performed qualitative, quantitative and investigational assays in compliance with Wyeth standard operating procedures, USP, EP, GMP, FDA and other regulatory requirements.

• Performed mathematical calculations, interpreted results, and recorded observations.

• Continually developed problem-solving skills.

• Identified basic technical issues, atypical or out-of-specifications test results.

EDUCATION

• 1999 M.Sc, University of Montreal, Quebec, Canada

• 1995 B.Sc, University of Montreal, Quebec, Canada

• 1991 French language official certificate, Ministry of Communication and Immigration

• Montreal, Quebec, Canada

QUALIFICATIONS/SKILLS

• Compendial testing (US Pharmacopeia/ National Formulary, etc)

• Statistical analysis.

• Dale Carnegie Leadership Training Program.

• Project Management Institute (Essentials of Project Management, How to Communicate Successfully)

• Six Sigma (Yellow belt)-improvement initiatives and the "professionalizing" of quality management functions.

• Compliance with SOP, FDA and GMP/GLP requirements.

• Oral Solid Dosage Manufacturing Technology Training.

• Computer skills: LIMS, Excel, Access, Empower, Word, SPSS, TrackWise, GXPharma, SPSS, StatView, MATLAB

• Language skills: French, English and Polish.

• Advanced Open Water SCUBA Diver.

REFERENCES

• References available on request.

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