Açıklama:
QUALIFICATIONS AND JOB DESCRIPTION
Founded in 1983, Sanovel is one of the leading companies within the Turkish pharmaceutical industry. Boasting an annual production capacity of 227 million units and EU GMP (Good Manufacturing Practices) certification, the company aspires to be a global pharmaceutical player. This vision is driven by robust R&D, an extensive product portfolio featuring over 60 brands and 180 products , and a dedicated team of over 1,600 individuals committed to fostering long and healthy lives. Sanovel is distinguished as the first and only Turkish pharmaceutical company to have obtained approval upon inspection by the American Food and Drug Administration (FDA), acknowledged as the world's foremost health authority, without encountering any major or critical observations. With exceptional capabilities in terms of R&D, patents and intellectual property rights, Sanovel is the pioneering company to offer equivalent products to the market in a wide range of treatment areas. Enjoying a leadership position in intellectual property competence within the industry, Sanovel has consistently maintained its status as the patent champion of the Turkish pharmaceutical industry, a title attributable to the company's exceptional work in the realm of intellectual property.
Guided by a strong vision, Sanovel centers its entire operation around sustainability, aiming for a balanced and valuable life for its hundreds of highly competent and passionate employees. The company is dedicated to contributing to the Turkish pharmaceutical industry and the national economy, a commitment it has upheld for four decades, with the overarching goal of promoting lifelong health worldwide.
We are looking for a CMO (Contract Manufacturing Organization) Project Executive to join our Quality Assurance team in Sanovel Silivri Factory.
Responsibilites
- Follow up contract manufacturing organization (CMO) agreements’ signing, revising, and negotiating processes between contract giver (CG) and contract acceptor (CA) parties,
- Responsible for coordinating and managing meetings for related technical affairs with customer,
- Prepare quality quotations for new projects which will be produce in CA facilities for the first time,
- Leading the Technology Transfer Process to ensure timely completion of transfers and coordinate between departments,
- Communicate with senior management and export department to meet their expectations and check solutions for problematic processes to develop solutions oriented and proactive strategies for contract manufacturing,
- Responsible for development of production organization with internal departments (particularly Planning and QA, Artwork, Logistics, R&D, Purchasing) and contract manufacturing companies according to GMP and quality agreements,
- Attend weekly planning meetings for ensuring orders to delivery before deadlines,
- Work in close with batch release department to monitor release processes of finished goods,
- Initiate and perform change controls about new products implementation, batch size changes, alternate equipment etc.,
- Perform coot cause investigations against deviations, out of specifications and customer complaints for customer products,
- Manage and assist the validation processes of new products and coordinate relations in the company. Track of the validation and stability protocols with batch records of processes,
- Responsible for leading project teams and managing all activities in a project life-cycle (initiation planning, executing/controlling, and closing) associated with projects that are long-term, line of business-wide and medium to high in risk, scope, complexity,
- Consults with business partners to clarify and define project requirements and business case, including development of a statement of work,
- Develops and revises complex project plans and budgets, works with users to understand complex problems and focuses on bringing issues to resolution, escalating as necessary to meet timelines,
- Responsible for end-to-end project management, demonstrating ownership of the entire process from beginning to end, Performs project risk analysis,
- Develops and implements program and project level processes, procedures and performance metrics,
- Responsible for sourcing, negotiating and managing outside vendors,
- Manage a program or a series of projects associated with a specific business function,
- Managing and directing the project during meetings with international clients (online & face-to-face).
- Monitoring the team's work processes, supporting and developing the team through a coaching & leadership approach, including training and providing input to performance evaluations.
Qualifications
- Graduated from Chemistry, Chemical Engineering, Pharmacy, etc.,
- A total of 8 years of pharmaceutical industry experience, minimum 5 years of experience in quality, quality assurance, validation, etc.
- Able to manage all quality requirements in the processes they conduct in compliance with regulations and health policies set by health authorities, and capable of being accountable for decisions and actions taken in this regard when necessary
- Having a quality-oriented and proactive approach,
- Able to generate solutions in the face of problems with an analytical perspective and guide teams effectively,
- Focusing on development and willing to help others grow with coaching and leadership skills,
- Have a good command of English,
- No military obligations for male candidates.
We believe that what makes each of us unique and valuable is our perspectives, lives, backgrounds and differences. We do not discriminate based on ethnicity, religion, language, race, age, gender, sexual orientation, nationality, disability or cultural difference, and we provide an equal employment opportunity in all human resources processes.