Mine Gulmen
Angestellt, Lead Engineer, No Deviation Pte Ltd
Singapore, Singapur
Über mich
Experienced pharmaceutical/ biotech industry professional with 14 years’ experience mostly in Quality & Compliance. Possesses deep knowledge of pharmaceutical/ biotech Quality Management Systems (QMS). Extensive experience in Commissioning, Qualification and Validation (CQV) activities (including Review, Change Controls, Deviation Management) on a wide selection of systems (process equipment, utility systems, cleanrooms, HVAC and BMS) involved in drugs and biologics manufacturing processes. Experienced in CAPA management, quality gap assessments, internal and external audits. Demonstrated history of effective communication, facilitation, coaching, and project management in cross-functional and multicultural teams. Well-familiar with working in dynamic environments under tight deadlines. Extensive knowledge and experience in application of quality regulation standards and guidelines (cGMP principles, ISPE Baseline guides, ICH Quality Guidelines, GAMP5, ASTM E2500, ISO 9001).
Werdegang
Berufserfahrung von Mine Gulmen
Bis heute 8 Jahre und 7 Monate, seit Dez. 2015
Lead Engineer
No Deviation Pte Ltd
Amgen Manufacturing Singapore (Mar 2022 – present) as Sr. CQV Engineer In-house project: ISO 9001:2015 Compliance (Feb 2022) MSD (Merck Sharp & Dohme) Singapore (Jan 2021 – Sep 2021) as Sr. Validation Engineer Novartis Singapore (Jun 2017 – Apr 2021) as Engineering Compliance Expert Abbvie Manufacturing Plant Project Singapore (Dec 2015 – May 2017) C&Q Engineer
2 Jahre und 8 Monate, Apr. 2013 - Nov. 2015
Validation Consultant
CONVAL GROUP
Designs and implements qualification activities of - Process equipment - Purified water systems - Compressed air systems - Building management systems (HVAC) - Quality management systems
4 Monate, Juni 2011 - Sep. 2011
Business Management Project Participant
Trumpf Group
Developed a “Lead Indicator Management” system for internal steering and external prognosis for the two main divisions of Trumpf, Machine Tools and Laser Technologies, as part of the international team of four Mannheim MBA participants.
2 Jahre und 2 Monate, Okt. 2006 - Nov. 2008
Product Manager
Intendis (Bayer HealthCare)
• Prepared annual brand plans in accordance with sales and EBIT targets • Analyzed market research data • Established up-to-date marketing strategies • Created initial versions of marketing aids by thorough scan of proof sources • Coordinated all associated medical marketing events • Made key customer visits • Trained new sales reps • Prepared P&L scenarios taking into account price changes and product life-cycle
2 Jahre und 2 Monate, Juli 2004 - Aug. 2006
Validation Engineer (Quality Assurance)
Abdi Ibrahim Pharmaceuticals
• Executed qualification of the Building Management System (HVAC) within a team of consultants, vendors and employees of validation, electrics and mechanics departments • In charge of performance qualification of HVAC, pressurized gas and water systems • Created system validation SOPs
Ausbildung von Mine Gulmen
1 Jahr und 1 Monat, Sep. 2010 - Sep. 2011
Management
Mannheim Business School (in coop with Warwick Business School and EADA)
2 Jahre und 6 Monate, Feb. 2001 - Juli 2003
Chemical Engineering
Bogazici University
Molecular modelling and simulation, heterogeneous catalysis, CO oxidation, Pt-Sn catalysts
3 Jahre und 11 Monate, Sep. 1996 - Juli 2000
Chemical Engineering
Bogazici University
Sprachen
Englisch
Fließend
Deutsch
Gut
Türkisch
Muttersprache