Ferda Batum Email & Phone Number

Turkey

Responsible for overall leadership of the Site's operational performance in financial, quality, services, productivity,safety, employers relations and supply chain management.Created a vision and operating strategy to drive Site transformation project in align with 5 year strategic business plan.

Istanbul, Turkey

Provided strategic leadership to a team of 240 employees with accountability for a $15.8M budget and 57.5M packs. Oversaw Site Quality Team as well the implementation of quality standards throughout the entire Site.

Responsible for the governance of the technology transfer activities from the clients. Provided management of the team to continuously improve CMO governance processes with external partners, leading keu meetings and agendas, maintaining efficient issue escalation and resolution processes.

Integrated and implement GMP standards in order to support the manufacturer of quality cosmetic and soap products.Building and nurturing direct relationships with international customers with respect to contract manufacturing.

Responsible for final release and approval of marketed products, quality compliance, documentation, validation, GMP auditing, packaging design & control, In-process control, change control, deviations, CFI investigations, GMP training.Providing support for the newly constructed pharmaceutical manufacturing facility:Worked closely with Site Leadership to establish and implement compliance and GMP improvement initiatives to fully bring the new Site readiness for EU and FDA inspections, andPromoted efforts based on validation-driven objectives in qualifying and validating activities in accordance with Validation Master Plan.Participated in an audit by the MHRA inspectors and secured approval to export finished products to EU market. Completed the transfer of almost the number of 130 finished drug products with performing process validation form the old manufacturing Site to the new Site in under 12 months.

Facilitated Pfizer Quality Standards Compliance Project to establish and maintain approximately 145 Quality Standards; coordinating with relevant departments in developing and implementing action plans.Operated as an active member of the GMP Trainer's Network and contact person for the regional AfME GMP Trainers champion by coordinating and communicating training activities within Site members.Played an active role in the establishment of the Validation section; hiring new employees, promoting validation policy and establishing standards in compliance with PQS.Participated in the Learning and Training Team; conducted an analysis of PGM Learning & Training and recommended a global approach to the Global Leadership Team to improve effectiveness and efficiency of Learning / Training.Played an active role in Product Based Process Capability (PBCpk) Core Team to conduct PBCpk studies to proactively assess the current capability of our process and continually strive to improve our Cpks.Operated as the qualified Green Belt in Right First Time organization to conduct six sigma projects to improve RFT metrics.Coordinated the Site Quality Review team to facilitate the management team; responsible for taking and driving Quality decisions.

Managed production operations, scale up, process improvement, trouble shooting, validation, training, process and equipment optimization.Led $2m US Wet Granulation plant project and managed the project team through the development, installation and validation phases.Managed $1.2m Blister Optimization Project to increase the capacity utilization and increase the overall efficiency level.Organized a project team to upgrade the Non-Penicillin manufacturing facility for three consecutive years to ensure that all manufacturing operations fulfilled cGMP requirements and PQS. ($1.5m US project)Initiated various Cost & Quality Improvement Projects throughout manufacturing lines to increase the line efficiency and provide cost savings.

Managed the manufacturing of solids, semi-solids, and liquid dosage forms according to Pfizer standards.Supervised and ensured that operations environment is in compliance with respect to cGMPs, safety, regulatory requirements and Pfizer Quality Standards.Developed and performed training sections for manufacturing members.Performed and evaluated operational performance including labor and equipment utilization, product variances, direct and indirect expenses, overtime and operations yield.

Participated in performing aseptic validation activities with Fluor Daniel consultant during commissioning of the new beta-lactam and cephalosporin plants.

Industrial Engineering

Education record

Education record