Shaindel Duenas
Rheinfelden
Summary
Authentic Quality leader with 20+ years of progressive career in the pharmaceutical Industry. Extensive exposure to audits and Health authorities’ inspection, (FDA, EU & other's stringent regulatory bodies), with successful outcomes. Committed to high standards and successful QA strategies and processes. with expert team leadership, planning and organizational skills built during successful career. Organized, with proven ability to prioritize work demands, foresee possible setbacks, and establish corrective measures to optimize use of time and resources.
Overview
13
13
years of professional experience
Work History
Sr. Quality Manager, Strategy & KPI Management
BAYER Consumer Health BCC AG
04.2023 - Current
- Developed and fully implemented Global Quality strategy, with impact on the whole network of manufacturing sites of Bayer Consumer Health Division
- Developed Key Performance Indicators (KPI) / KPI strategy in connection with business needs for the CH division growth strategy and presented it to the management and led to execution plan
- Assessed the enterprise quality risk across the network as an input to the annual divisional quality strategy review and articulated results in the Divisional Quality Plan.
Divisional CH Quality Business Partner APAC & EMEA
BAYER Consumer Health
07.2020 - 04.2023
- Directed Quality Management systems (QMS), and other country specific requirements to ensure adherence to cGxP quality and regulatory standards applicable to the company’s extended product ‘portfolio
- Improved Quality performance of Regional Internal Manufacturing Network with sustained excelling results in quality management reviews consecutively three years
- Developed strong partnership with cross-functions to drive a network design strategic initiative to unlock efficiency and resilience
- Managed GMP' Quality reviews and approval of Capital site’s investment “GMP/GDP upgrade projects” at the CH sites within the regions w/ cost over 50 million euros
- Developed regional QA succession planning in close interaction with site management.
Site Quality Head
BAYER Consumer Health
03.2017 - 07.2020
- Built solid and robust QMS with proven tracked records of substantial compliance in front of several Health Authority inspections
- Successfully HA Inspection's outcomes that secured licenses to operate and the ability to distribute products in more than 28 countries
- Led a team of +100 employees building capabilities for Cimanggis to become strategic OTC CH site in APAC region
- Earned recognition “Bayer LIFE Awards 2018” in the category “Leadership” given by Indonesia country platform by the transformation of Cimanggis site
- Driven multiple Quality continuous improvement initiatives to operational effectiveness and efficiencies within all quality functions at the site generating savings over 500K.
QA Manager Contract Manufacturing
BAYER Consumer Health
03.2015 - 03.2017
- Optimized acquired network of suppliers with the objective to support the growth of the acquiring leading product brands that will make Bayer the OTC leader and position Bayer as the top global in key OTC product categories
- Overseen Bayer OTC portfolio manufacturing activities at 15 CMO's spread in diverse regions: EMEA, APAC, NA to ensure the suitability of products according to Bayer standards, and applicable market regulations
- Conducted GMP Audits, prepared audit reports, and followed-up on audit CAPA at the CMO to ensure timelines completion
- Revised Quality Documentation including batch records, CoA’s, deviations, CAPA, Complaints, Change Controls, OOS investigations, and Stability data
- Attended operational meetings to support continuity of business supply with regards to technical transfer activities
- Maintained multiple databases for tracking various quality data related to audits, deviation, change control, APR/PQR.
QA Associate APIs & Raw Materials
BAYER Consumer Health
10.2014 - 03.2015
- Ensured that APIs and Strategic Raw material suppliers utilized in CH Bayer Sites were compliant with appropriate manufacturing practices, met Bayer quality standards and the applicable regulatory agencies
- Established and implemented DQAA / LQAA with API/RM suppliers and customers
- Qualification of suppliers by collecting and evaluating supplier’s documentation and insertion in system trackwise
- Led supplier qualification workplan of (4) acquired manufacturing sites which enabled the business to operate continuously in compliance and according to Bayer processes
- Performed more than 100 Risk Assessment for API/RM/GMP providers from acquired business to determine supplier audit frequency based on criticality; Planned and coordinated quality audits of API/RM/ and all GMP services providers
- Created Post Merger Integration Handbook as guidance for best sharing practices and potential future acquisitions.
QA Analytical Research & Development Technical Associate
APOTEX
08.2013 - 10.2014
- Reviewed and approved manufacturing records, SOP's, STP's, specifications, AMV, protocols, reports and method transfer for commercial and non-commercial products
- Prepared technical documentation to support filing submissions in USA, Japan, and AU
- Prepared batches of released documentation for each commercial product in support of annual product review (APR).
Analytical Scientist III
AVEVA Drug Delivery Systems
11.2010 - 08.2013
- Developed and validated Analytical Testing Methods: Physical Testing, Assay, Impurities and Residual Solvents to characterize and improve drug substance and drug product manufacturing processes
- Executed complex experiments in support of Research and Development of new formulations and validation of processes
- Executed excipient-API compatibility studies, solubility studies, forced degradation studies; and analyzed flux studies
- Authored analytical protocols, reports, SOP’s, specifications, and test procedures (STP’s)
Education
MS-RQC Graduate Program – Regulatory Affairs & Quality Compliance -
Purdue University
W. Lafayette, INBachelor of Science (BS) – Chemistry -
Florida International University
Miami, FLSkills
- Team Management, Leadership, Empathy
- Built strong Quality Management Systems
- Issue Management: Deviation, OOS, OOT Investigations, CAPAs
- HA Inspections FDA/EMA/ stringent Regulators agencies
- Strategy, KPIs, Quality Performance
- Risk Management, Remediation Plans & Continuous Improvement Initiatives
- Analytical Research & Development / Quality Control
- Ability to communicate with individuals from varying backgrounds and cultures
Awards
Bayer LIFE Awards 2018 “Leadership” Country Indonesia
Empowering the Transformation of Everyday Health 2019 through High-Performing Product Supply PT Bayer Cimanggis
Languages
English
Bilingual or Proficient (C2)
Spanish
Bilingual or Proficient (C2)
German
Intermediate (B1)
Indonesian
Intermediate (B1)
Timeline
Sr. Quality Manager, Strategy & KPI Management
BAYER Consumer Health BCC AG
04.2023 - Current
Divisional CH Quality Business Partner APAC & EMEA
BAYER Consumer Health
07.2020 - 04.2023
Site Quality Head
BAYER Consumer Health
03.2017 - 07.2020
QA Manager Contract Manufacturing
BAYER Consumer Health
03.2015 - 03.2017
QA Associate APIs & Raw Materials
BAYER Consumer Health
10.2014 - 03.2015
QA Analytical Research & Development Technical Associate
APOTEX
08.2013 - 10.2014
Analytical Scientist III
AVEVA Drug Delivery Systems
11.2010 - 08.2013
MS-RQC Graduate Program – Regulatory Affairs & Quality Compliance -
Purdue University
Bachelor of Science (BS) – Chemistry -
Florida International University
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