Aina Selles Email & Phone Number | Design, manufacturing, labelling and packaging of medication batches of investigational medical products developed at Almirall and used in worldwide Clinical Trials. Tasks: � Manufacture in a GXP environment of medication batches used in Clinical Trials and batches aimed at register investigational medical products developed in house by Almirall, mainly in the inhalation, dermatologic and gastrointestinal fields. - Writing and checking according to the current ICH regulation of manufacturing, primary and secondary packaging and labelling batch records. - Controlling and attesting the manufacturing activities under GMP guidelines. � Preparation and verification of the randomized clinical trial labels. - Checking of the fixed core text of the labels, in compliance with the current European Legislation (GMP Annex 13). - Design and production of labels. - Controlling the labels' checking, the labelling activities and the secondary packaging procedures. Preparation and checking of the documentation involved. � Development of methods and innovative designs of blinded medication for Clinical Trials, particularly .of comparators and their placebos in terms of manufacturing, primary and / or secondary packaging and labelling. � Management, organisation and design of pharmaceutical technology and clinical product development strategies concerning a time and cost decrease.Tasks: - development of formulations and manufacturing procedures of solid dosage forms of products under clinical research. - participation in the manufacturing activities. - characterisation and early formulation development de new active compounds aimed to be new development candidates. - helping in solving manufacturing problems. - preparation and verification of the randomized labelling activities of Clinical Trial's medication.Responsible for the accredited ISO 17020 quality management system to manage GMP and GDP 3rd party audits. Technical preparation and coordination of GxP third party audits to pharmaceutical industry suppliers (raw materials, packaging materials, distributors, analytical services, contract manufacturing, etc.) all over the world. Audit risk assessment based on sponsors requirements, applicable regulatory frames, previous auditee information. Technical review and issuance of audit reports.specialized in validation of computerized systems for the pharmaceutical industry. PhD students’ assistant at Kaohsiung Medical University (KMU), Kaohsiung, Taiwan, in the Pharmacologic and Botanical fields: - Transdermic absorption of anti-inflammatory substances - Intracranial accumulation of antiepileptic liposoluble drugs - Selection, extraction and characterisation of vegetal alkaloids by means of mass spectroscopy.

Aina Selles

Design, manufacturing, labelling and packaging of medication batches of investigational medical prod...
Barcelona, Barcelona, Spain

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Aina Selles’s Email aina.selles@rephine.com

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Aina Selles’s Location Barcelona, Barcelona, Spain

Aina Selles’s Current Industry Forum Auditorias

Aina Selles’s Prior Industry TDV SL | Labiana Pharmaceuticals SLU | Almirall I+D | National Kaohsiung University of Applied Sciense

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Work Experience

Forum Auditorias

Quality Assurance responsible

2015-11-01 00:00:00 - Present

TDV SL

Validation technician

2013-02-01 00:00:00 - 2014-05-01 00:00:00

Labiana Pharmaceuticals SLU

Regulatory Affairs Technician

2012-11-01 00:00:00 - 2013-02-01 00:00:00

Almirall I+D

Pharmacist at the Clinical Trial Unit

2010-02-01 00:00:00 - 2012-11-01 00:00:00

National Kaohsiung University of Applied Sciense

PhD assistant

2007-07-01 00:00:00 - 2007-08-01 00:00:00

Skills

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Languages

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FAQ About Aina Selles

Aina Selles is located at
Barcelona, Barcelona, Spain

Aina Selles is a Design, manufacturing, labelling and packaging of medication batches of investigational medical products developed at Almirall and used in worldwide Clinical Trials. Tasks: � Manufacture in a GXP environment of medication batches used in Clinical Trials and batches aimed at register investigational medical products developed in house by Almirall, mainly in the inhalation, dermatologic and gastrointestinal fields. - Writing and checking according to the current ICH regulation of manufacturing, primary and secondary packaging and labelling batch records. - Controlling and attesting the manufacturing activities under GMP guidelines. � Preparation and verification of the randomized clinical trial labels. - Checking of the fixed core text of the labels, in compliance with the current European Legislation (GMP Annex 13). - Design and production of labels. - Controlling the labels' checking, the labelling activities and the secondary packaging procedures. Preparation and checking of the documentation involved. � Development of methods and innovative designs of blinded medication for Clinical Trials, particularly .of comparators and their placebos in terms of manufacturing, primary and / or secondary packaging and labelling. � Management, organisation and design of pharmaceutical technology and clinical product development strategies concerning a time and cost decrease.Tasks: - development of formulations and manufacturing procedures of solid dosage forms of products under clinical research. - participation in the manufacturing activities. - characterisation and early formulation development de new active compounds aimed to be new development candidates. - helping in solving manufacturing problems. - preparation and verification of the randomized labelling activities of Clinical Trial's medication.Responsible for the accredited ISO 17020 quality management system to manage GMP and GDP 3rd party audits. Technical preparation and coordination of GxP third party audits to pharmaceutical industry suppliers (raw materials, packaging materials, distributors, analytical services, contract manufacturing, etc.) all over the world. Audit risk assessment based on sponsors requirements, applicable regulatory frames, previous auditee information. Technical review and issuance of audit reports.specialized in validation of computerized systems for the pharmaceutical industry. PhD students’ assistant at Kaohsiung Medical University (KMU), Kaohsiung, Taiwan, in the Pharmacologic and Botanical fields: - Transdermic absorption of anti-inflammatory substances - Intracranial accumulation of antiepileptic liposoluble drugs - Selection, extraction and characterisation of vegetal alkaloids by means of mass spectroscopy.

Aina Selles currently works in the Forum Auditorias |

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Aina Selles has prior
experience in the following industries:
TDV SL | Labiana Pharmaceuticals SLU | Almirall I+D | National Kaohsiung University of Applied Sciense

Aina Selles has the following professional experience:
Forum Auditorias | TDV SL | Labiana Pharmaceuticals SLU | Almirall I+D | National Kaohsiung University of Applied Sciense