- Ogłoszenie wygasło 23 dni temu
- Praca zdalna
- Pełny etat
Aurovitas Pharma Polska sp.z o.o. is a pharmaceutical company focusing on generic RX and OTC drugs covering 22 therapeutic areas, including: urology, neurology, psychiatry, cardiology and allergology. Aurovitas Pharma Polska was established as the third Aurovitas company in Europe and is part of the Aurobindo Pharma Group.
Aurobindo Pharma Ltd Malta is the gateway for Aurobindo’s pharmaceutical products in Europe. Celebrates 12th anniversary in operation and continues to grow. The latest project includes the launch of high-performance testing facilities. Therefore, require highly motivated and professional individuals with a strong work ethic to join the existing team.
We are currently looking for Candidates for the position:
Workplace: Warsaw - Malta
We are looking for a mature, organised and trustworthy individual, who is goal oriented and possesses meticulous attention to detail. This critical role within our organisation requires you to focus on the duties related to EU batch certification in accordance with regulatory requirements, and support the maintenance of the associated quality systems; as well as hosting or assisting in the conduct of customer and regulatory audits, and participate within the Aurobindo Global Vendor compliance program by performing vendor audits at facilities worldwide to ensure regulatory, client and internal company requirements are met.
The Position Requires:
- A registered EU Qualified Person. as defined by EU Directive 2001/83.
- A Bachelor’s Degree in Pharmacy, Chemistry or Biology, or equivalent.
- Good IT skills e.g. Microsoft Office (Word, Excel and Outlook).
- You to be a credible and confident communicator in English (written and spoken).
- You to be process driven and have the ability to achieve and maintain high standards with meticulous attention to detail.
- You to have the proven skill to cope with a wide variety of tasks and changing priorities.
- You to have the ability to work accurately in a busy and demanding environment whilst adhering to strict deadlines / timescales.
Tasks and Responsibilities
- Release of batches in accordance with the Marketing Authorisation, the Manufacturing
- Authorisation, GMP and legal requirements.
- Assistance in the investigation of quality related deviations and customer complaints, and support execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained.
- Review and approval of manufacturer’s change requests.
- Co-ordination of return/s and recall/s along with Manager, Quality Unit.
- Quality audits of Aurobindo and third party API and finished dosage form manufacturing sites.
- Signing GMP declaration forms for API suppliers as appropriate and when required.
- Quality audits
- Review and approval of periodical Product Quality Review.
- Assist in the generation, review or approval of Standard Operating Procedures, Corporate Policy
- Statements and other defined critical documentation.
- Assist and participate in internal GMP training sessions and training requirements within the
- Quality Unit, as well as coaching of personnel for QP eligibility.
- Review and approval of validation documents.
We offer three options of employment:
- Moving to Malta and employment by Aurobindo Malta
- Living in Poland and employment by Aurovitas Poland
- Free-lance QP (B2B agreement)
Prosimy o zamieszczenie klauzuli: „Wyrażam zgodę na przetwarzanie moich danych osobowych dla potrzeb niezbędnych do realizacji procesu rekrutacji (zgodnie z ustawą z dnia 10 maja 2018 roku o ochronie danych osobowych (Dz. Ustaw z 2018, poz. 1000) oraz zgodnie z Rozporządzeniem Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE (RODO))
Uprzejmie informujemy, iż zastrzegamy sobie prawo kontaktu jedynie z wybranymi osobami