Quality director

ONLY THE PERSONS WHO MEET THE CRITERIA SHOULD APPLY.
DEADLINE FOR APPLICATIONS: 10.03.2016

CANDIDATE:
- Graduate in: Pharmacy, Medicine, Chemical Engineering, Chemistry or Biology;
- Relevant experience of minimum 3 years in the Pharmaceutical Industry (preferably in Quality Assurance);
- Experience of minimum 1 year in a management/leading position in a department or a compartment;
- Postgraduate or training courses/programs are a plus;
- The status of Qualified person is a plus, but not mandatory;
- Knowledge and/or experience in Regulatory affairs is a plus, but not mandatory;
- Very good English and Romanian (writing, speaking, listening);
- Very good PC operating skills (Word, Excel, Internet, etc);
- Dynamic and organized person, with leadership abilities;
- Intuitive, self-learner, capability to adapt to various legal and regulatory requirements and implement them;
- Very good knowledge of specific regulations in the Pharmaceutical industry (GMP, GLP, etc) and general Quality assurance standards (ISO 9001:2008 / ISO 9001:2015, ISO/TS 16949, ISO 14001:2005, etc);

JOB DESCRIPTION:
- Overall, reorganizes the activities of the Quality Department in order to meet current regulations and legislation;
- Implements and controls the compliance with GMP regulations and other applicable standards;
- Coordinates, controls and approves the editing or creation of specific documents for the manufacturing and quality control of medicines and food supplements.
- Coordinates, controls and approves all the standard operating procedures;
- Organizes the qualification of equipment and the validation of methods and processes; approves the protocols for qualification/requalification and for validation/revalidation;
- Participates, together with the colleagues from other departments, in establishing corrective and preventive measures in case of nonconformities;
- Organizes internal audits and audits at the suppliers of active substances, excipients and packaging materials;
- Communicates with the competent authorities, where it is the case;
- Participates in investigating and resolving quality complaints;
- Provides support and collaborates with the colleagues from Regulatory affairs department and other departments, in order to update or create the required documentation for the registration of medicinal products;
- The job is based in Chişinău, Republic of Moldova;
- If required, the company provides assistance with the working permit in the Republic of Moldova and assures accommodation, if the selected candidate comes from another country.
- Good remuneration and excellent opportunities for professional development;
- You can send your CV, together with the Letter of intent to office@sunviro.com. Only the selected candidates will be contacted.