Jovan Jelic
CSV Manager, Technical Engineering
Experience
CSV Manager, Technical Engineering
CureVac Printer GmbH
- Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met
- Coach implementation teams in the proper execution of validation documents
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Coordinate audits of internal computer systems validation activities, protocols and procedures, and prepare responses
- Identify and qualify all computer systems impacting cGMP operations using a risk-based methodology
- Develop CFR Part 11 computer systems validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ protocols and all deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage their execution
- Act as CSV lead for all validation projects and execute or oversee validation plans and documents
- Perform project management activities for the CSV process within the scope of system projects
- Work with project manager to include validation activities in implementation timelines
- Manage internal CSV resources to facilitate completion of qualification activities
- Ensure initiation, preparation and closeout of all CSV-related deviations, discrepancies and change control documents
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Conduct or facilitate validation and 21 CFR Part 11 training
Formulation and Process Development Senior Specialist, R&D Department
Hemofarm AD (STADA group)
- Work on pre-formulation and formulation activities and selection of primary packaging
- Develop processes for new or modified products and transfer products from development to production
- Prepare development, registration and supporting documentation for new or modified products
- Develop operating procedures, work instructions and documentation for laboratory and pilot equipment
- Monitor trends in pharmaceutical technology, chemistry and pharmacology to propose new projects and ideas
- Ensure quality of activities, schedule compliance and adherence to quality systems and relevant regulations
- Monitor activities defined by the work plan, continuous trend monitoring and knowledge creation
- Supervise and coordinate work of galenic development associates
- Educate colleagues, write scientific and professional papers and patent applications
- Participate in professional seminars, congresses and global project evaluation teams
- Act as deputy to the manager of galenic development
Independent Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
- Solve technological problems in production and suggest improvements to quality, quantity and productivity
- Organize and implement validation processes for production segments and equipment
- Propose new technological procedures, equipment and work organization
- Participate in product transfers and validation of production segments with relevant services
- Write operational procedures and work instructions
- Propose measures for non-compliant product batches
- Ensure adherence to work discipline, SOPs and corporate regulations
- Implement measures to ensure specified yield for each stage of production and packaging
- Improve and implement good production practices and safety and health measures
Senior Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
- Solve technological problems in production and improve production quality and quantity
- Organize and implement production validation processes
- Follow global trends in pharmaceutical production development
- Operate information systems according to SOP requirements
- Participate in validation of production segments, equipment and product transfers
- Create operating procedures and work instructions
- Ensure work discipline, corporate rules and SOP compliance
- Implement good manufacturing practice policies and safety measures
- Train employees and prepare reports as required
Expert Associate and Deputy Team Leader, Tableting and Film Coating Department, Solid Dosage Forms
Hemofarm AD (STADA group)
- Participate in solving technological production problems and product transfers
- Validate production segments and equipment and ensure correct technology application
- Control individual production stages and optimize raw material consumption
- Propose production improvements and implement good manufacturing practices
- Use information systems per SOP guidelines
- Develop and implement operating procedures and work instructions
- Train department employees and follow professional literature
- Ensure work discipline, SOP and safety measure compliance
Process Engineer
SR Dineflon
- Organize production and manage workers
- Identify new production opportunities and solve production issues
- Manage procurement and handling of raw materials
- Participate in marketing presentations for potential customers
- Ensure timely and high-quality task execution and rational use of resources
- Implement measures to ensure specified yield for production and packaging stages
- Ensure safety and health at work measures
Summary
Motivated and experienced Chemical (Process) Engineer with over 9 years of experience. Proven track record of solving problems, reduce overall costs and configure the best approach for the most seamless and effective production. I’m highly committed, and goal orientated with excellent interpersonal skills, leadership, and people management. My colleagues and partners recognize me as a decision-maker with great ability of creative thinking.
Skilled in Manufacturing of Solid Dosage Forms and in Galenical Development. With more than 5.5 years in pharmaceutical industry I’ve specialized in solving of technological problems, development and improving production of laboratory batches and commercial batches. I’ve specialized in projects of new tablet machines, drum coaters form URS phase, technical analysis, FAT, starting MOC, writing SOP, managing people from other departments to make possible installation of machine on site in specific place, SAT, IQ, OQ, to PQ. I’ve specialized in Computer System Validation, Data Historian and On-going Process Validation. I’ve specialized in statistical problem thinking using Minitab and JMP software.
Skills
Computer Skills: Ms Office, Edms, Eqms, Sap, Minitab, Amlexor, Jmp, Autocad, Matlab, Fortran 77
Manufacturing: Gmp, Tableting Of Single Layers And Bilayers Tablets, Tableting Minitablets, Capsules, Film Coating Of Tablets, Wurster Coating Of Mini Tablets, Tableting With Single And Multi-tip Tools, Sugar Coating, High Shear Granulation, Fluid Bed Granulation, Direct Compression, Dry Granulation, Capsuling Of Minitablets, Immediate And Modified Release Formulation Of Tablets, Formulation Of Film Coating, Optimization Of Immediate And Modified Release Tablets, Optimization Of Bilayer Tablets, Technical Documentation, Sops, Daily/weekly/monthly Planning Of Production, Doe, Predictive Modeling And Text Mining, Correlation And Regression, Decision Making With Data, Quality Methods, Exploratory Data Analysis, Statistical Thinking And Problem Solving
Soft Skills: Time Management, Assertive Communication, Adaptability, Problem Solving, Teamwork, Creativity, Leadership, Interpersonal Skills, Work Ethic, Attention To Detail
Languages
Education
Faculty of Technology and Metallurgy, Universaty of Belgrade
University degree in Chemical Engineering – Dipl. Ing. of Technology · Chemical Engineering · Belgrade, Serbia
Certifications & licenses
Facilitation Body Language
QbD Process Validation
Root Cause Problem Solving
Lean Six Sigma Green Belt
First Certificate In English
Profile
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