Mihaela Rosca Email & Phone Number

Zurich, Switzerland

Cluj County, Romania

Ferrosan is a producer of consumer healthcare goods, part of GSK. In 2020 the company was sold by Pfizer to GlaxoSmithKline.Coordinating the activity of Physicochemical Laboratory, Stability and Retains activities. Managing a team of 6 quality control specialists.Responsible person for quality compliance of the analytical testing for all the products (raw materials, packaging materials, bulk and finished products for releasing and stability) by the Physicochemical Lab and contracted external laboratories. Assure that GMP, ICH, GSK procedures are strictly followed and applied in quality control operations.Verifying and approving a wide range of QC documentation: procedures, specifications, certificates of analysis, stability protocols, reports and statistic, validation protocols and reports, sampling plans, forms etc. on paper or in electronic systems. Assure that quality documentation conforms with Pharmacopoeias, GSK procedures, Regulatory requirements.Make sure that all the laboratory equipment used for analytical testing are qualified/ validated/ calibrated. Assure that electronical systems used for QC (LIMS, Empower, other) complies. Responsible with stability samples and retains management.Correcting implementation of procedures (SOP) related to lab, stability, retains and their review.Make sure that out-of-specification results are accurately investigated and documented.Member of investigation team of the site, responsible with solving deviations and events by applying Six Sigma -Method 1 concept, methodology LEAN/DMAIC for solving problems.Member in Site Quality Review Team.Delivers/schedule department GMP, SOP and technical training programs. Make sure that the department is properly trained as per approved curriculum. Monitor objectives and key performance indicators for the department.Work close with GSK colleagues from Italy.

Cluj, Romania

Coordinating the activity of Physicochemical Laboratory, Stability and Retains activities. Managing a team of 6 quality control specialists.Responsible person for quality compliance of the analytical testing for all the products (raw materials, packaging materials, bulk and finished products for releasing and stability) by the Physicochemical Lab and contracted external laboratories. Assure that GMP, ICH, Pfizer procedures are strictly followed and applied in quality control operations.Verifying and approving a wide range of QC documentation: procedures, specifications, certificates of analysis, stability protocols, reports and statistic, validation protocols and reports, sampling plans, forms etc. on paper or in electronical systems. Assure that quality documentation conforms with Pharmacopoeias, Pfizer procedures, Regulatory requirements.Make sure that all the laboratory equipment used for analytical testing are qualified/ validated/ calibrated. Assure that electronical systems used for QC (LIMS, Empower, other) complies. Responsible with stability samples and retains management.Correcting implementation of procedures (SOP) related to lab, stability, retains and their review.Make sure that out-of-specification results are accurately investigated and documented.Member of investigation team of the site, responsible with solving deviations and events by applying Six Sigma -Method 1 concept, methodology LEAN/DMAIC for solving problems.Member in Site Quality Review Team.Delivers/schedule department GMP, SOP and technical training programs. Make sure that the department is properly trained as per approved curriculum. Monitor objectives and key performance indicators for the department.Work close with Pfizer colleagues from Italy and Denmark.

Terapia Cluj

Coordinating the entire activity of the Lab including method development and validation, verifying the validation protocols and reports, managing a team of 10 analysts.Validating the entire documentation coming from the lab (primary data, chromatograms). Review and approve laboratory procedures, in Romanian and English languages.Supervising all the qualification activities of the equipment and performing routine inspection of the equipment. A wide range of Administrative tasks (work orders, inventory etc.).Work with colleagues from Ranbaxy, India.

Cluj, Romania

2005- 2008 Part of Bioanalytical Lab, Bioequivalence and Bioavailability Department. Developing, validating, and applying bioanalytical methods for biological samples.1995- 2005 Part of Quality Control Department. Elaborating, validating, and implementing new HPLC methods for quantifying the active ingredients from pharmaceutical products, prepare the specific documentation. Cleaning validation of equipment.Preparing validation protocols and reports for analytical methods.

Master'S Degree, Heterocyclic Compounds

Bachelor’S Degree, Chemistry