- A challenging role responsible for the internal and external audits with purpose to ensure operations are in accordance with established guidelines
- Reporting to: Material Sourcing and Compliance Manager
Duties and Responsibilities
- Conducts internal and external Compliance Assessments of Actives/Excipients and Packaging Materials supplier facilities based on the EU cGMP. Develops audit plans, conducts quality audits, prepares audit reports and communicates findings, including compliance risk.
- Reviews and evaluates Suppliers audit responses against current regulations and guidelines to assure compliance. Follows-up on corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
- Maintains supplier database and determine final supplier approval status.
- Revises, reviews, and writes SOPs and checklists, as needed in order to complete required audit tasks.
- Reviews, approves or rejects DMF and other documents needed to be submitted to the competent authorities in order to obtain or renew the Marketing License of company’s products.
Qualifications and Experience
- University degree in a scientific field (preferably Chemistry or Chemical Engineering).
- Minimum of 2 years of QA/QC experience.
- Experience in the pharmaceutical industry and especially in pharmaceutical quality audit will be considered as an advantage.
- Ability to interpret regulatory guidelines/legislation.
- High level of integrity & ethical standards.
- Excellent time management skills.
- Ability to travel both domestically and internationally.
- Strong analytical and communication skills.
- Problem-solving abilities.
- Excellent command of the English language
- Computer literacy with working knowledge of MS Office applications.
An attractive remuneration package depending on qualifications that includes 13th and 14th salary, Provident Fund, medical cover, discount scheme is offered. Interested candidates should apply online through Remedica’s website https://www.remedica.eu/careers/