Dumitru Roxana Email and Phone Number

Responsibilities:- Preparing CMC documentation for regulatory submissions (modules 32S, 32P, QOS compilation for new submissions in EU ∕ non EU countries: VN, GE, BG, CY, MD), ensuringcompliance with the relevant authorities’ regulations/ interpretations;- Managing and review of information from/to other departments (including Research& Development, Manufacturing, Quality, Marketing and Clinical) regarding Regulatory submissions;- Preparing the quality specifications for excipients according with current Eur. Ph monograph;- Updating the dossiers with country specific requirements: CPP, stability data zone IVb.- Tracking and maintaining the specific local registration requirements; - Follow up on the assigned tasks and deadlines

Responsibilities:- Maintenance of Regulatory Database in order to ensure its reliability at each moment;- Revise the information in the Alvogen Database for new approvals and existing projects;- Work closely with all local affiliates in order to ensure that accurate information is timelyincluded;- Verify/ prepare and send the required information/documents to the PV Department (newmarketing licenses, renewals, transfers, safety variations, changes in the EVMPD, changes inthe SmPC/PIL);- Provide training sessions for new employees regarding the use of Alvogen Database;- Follow up on the assigned tasks and deadline;- Record and maintain the specific local registration requirements observed during dailyactivities;- Provide prompt support to other departments (Pharmacovigilance, Supply Chain, BusinessDevelopment).- Stay up to date with the EU and non-EU requirements, knowledge about electronic submissions

Responsibilities:- Planning and establishing work schedules, assignments and production sequences to meetproduction targets;- Responsible for qualification of equipment and validation of technologic processes;- Drawing internal procedures to keep up to date the processes and documents in order toreflect the current operational requirements; 2- Ensuring the implementation and use of SOPs;- Perform process investigations;- Monitoring the validation/certification protocols and maintenance, calibration, cleaningprocesses;- Ensuring implementation of corrective and preventive measures to improve productionprocesses;- Participation to audits carried out in the production unit;- Identifying consumption needs of raw materials

Responsibilities:- Organizing and supervising the technology of bakery products;- Monitoring and optimizing the parameters of the technological flow;- Setting production recipes depending on the quality indicators of raw materials;- Preparing technical documentation for each production line (working procedures, guidelinesand technical specifications).- Developing and testing new products and ingredients (conditioners, yeast, substitutes);- Setting the weekly and daily output plan;- Preparing monthly reports for the production department;- Supervising the management of finished products warehouse (GRNs-Goods ReceivedNotes), invoices, returned assets, delivery orders, stock rotation)

Main Responsibility: Monitoring the sterilization processes of company’s products.

Responsibilities:- Supervising operations to comply with all applicable safety laws and regulations, as well ascompany safety policies, procedures and standards;- Preparing production reports;- Maintaining working relationship with various suppliers;- Basic accounting skills.

- Supervising technological flow;- Ensuring that production meets health, sanitation and quality standards;- Maintaining safe and clean work environment by educating and directing personnel on theuse of all control points, equipment, and resources;- Preparing supporting documentation in order to assure the traceability of the finishedproducts;