Malik Osmane teilweise verfügbar

Malik Osmane

Pharma; Medical Device; Combo; Engineering; Validation; Compliance; QA; ICH; 211; 13485; 820;

teilweise verfügbar
Profilbild von Malik Osmane Pharma; Medical Device; Combo; Engineering; Validation; Compliance; QA; ICH; 211; 13485; 820;  aus Basel
  • 4058 Basel Freelancer in
  • Abschluss: nicht angegeben
  • Stunden-/Tagessatz:
  • Sprachkenntnisse: arabisch (Grundkenntnisse) | deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (verhandlungssicher)
  • Letztes Update: 11.07.2016
Profilbild von Malik Osmane Pharma; Medical Device; Combo; Engineering; Validation; Compliance; QA; ICH; 211; 13485; 820;  aus Basel
Are you looking for an experienced professional with a track record of successful and broad quality and process engineering experience within the life science industry? I deliver quality work, regardless of circumstances and was praised for my adaptability and creativity to come up with innovative solutions. I possess a mature skill set to make those solutions a reality in your company and within your resource limits. I am particular flexible for project-, freelance-, part time- and temporary-work and will deal efficiently with your bottle neck issues. I will deliver smart strategic guidance, education and hands on execution particular for innovator and biosimilar for QbD based development and process validation projects. I am determined to work hard to achieve your business goals, since your success is mine and I love to be successful!

Team Lead Qualification Validation QA (Basel)
(Quality Validation, part of ROCHE Basel Biotech PTBBQ. Launch site for advanced antibody based therapies)
1.       Management and development of a team of two QV-managers in the area of ??process validation
2.       Coordination and managing of process validation projects as an interface between production, development and other support departments in the local and global context
  • Part of the launch site project, exposure to process transfer. Inter site process validation strategies embedded in a life-cycle approach.
  • Supporting the update of dossier, due to site and scale changes
3.       Developing strategies in cross-departmental team for the implementation of internal and external GMP requirements, particularly with regard to process validation and Quality Risk Management (QRM)
  • Analysis of PV-best practice gaps and initiation of short- and mid-term measures.
  1. Successful preparation of two internal inspections, as part of an effort to prepare for an FDA inspection.
  2. Introducing a site wide QbD specialist training, highly appreciated by my peers.
2012-2015 Support Engineer (Berne)
(Qualification and Validation Group, part of the Vaccine Analytical and Process Development department of CRUCELL AG. CRUCELL is an innovative vaccine company part of the JnJ-family)
  1. Representation of the domain of responsibility in the inspection and audits
    • Preparing the QV-group for inspections, by informal internal inspection for example.
    • Representation of the group in inspection preparation meeting
  1. Creation of validation and qualification concepts. Development of PV strategies focused on development (ICH 8-10 series)
  • Participation in the JnJ e2e process validation project (global JnJ)
  • Initiating/Participation in various (QbD/PV) groups/projects (Crucell), such as QbD for vaccine development.
  • Coordinate implementation of validation and qualification concepts and systems in collaboration with PD and QA departments.
  • Make presentations aimed to share information on optimized/new validation and qualification concepts and systems with involved departments or groups (training).
  1. Coordinate and support sub-projects activities in the scope of solving interdisciplinary issues within project timelines.
  • Troubleshooting any managerial task in the areas of Q-systems, purchasing, resource-organization
  • Building and maintaining new systems/processes for the QV-group
  1. Support the other team members for operational qualification or
validation aspects
  • Taking on new operational tasks in bottle neck situations
  1. Development and roll out of an state of the art biotechnology process validation concept.
  2. Measurable increase of GMP compliance and audit proficiency of the QV-group.
2006-2012 Technical Service Scientist (Dublin)
(Technical Service Department, part BIOTRIN International supply chain. BIOTRIN is a diagnostics manufacturing and development company, part of the DIASORIN corporation)

1.  Leading failure investigations of mainly technical issues for technical manufacturing, as part of the CAPA system:
  • Trouble shooting O.O.S. results, root-cause investigation and full GMP-conform administrative part (ISO13485, 21CFR820) through implementation of validated corrective and preventive actions.
2.  Leading process- monitoring/improvement projects with focus on enhancing effectiveness of current procedures/processes:
  • Based on statistical analysis (Minitab) issues were detected and highlighted prior resulting in O.O.S.
  • Process re-design and process validation, involving complex systems such as filling equipment and resulting in measurable process yield increase. Providing technical documentation and support to update the DHF.
3.  Follow-ups as a result of CAPA’s in form of projects and studies:
  • Technical support for the development for new products and technical support for the risk ranking of new products/processes.
  • Updating product design SOP to include new process development requirements.
  • Support to introduce a CTQ-flow down model for product development similar to ICHQ8.
4.  Defending the scope of my work in audit situations and conducting internal audits
  1. Managing the Technical Service Department at interim for 5 month.
  2. Various process improvements projects, resulting in measurable increase of quality.
  3. Development of new analytical tools such as an ELISA based assay (semi quantitative).
  4. Development of a cross-functional database allowing to prevent issues and to track key data over time.