AddressSenior Executive-Quality Assurance
About Bluefish Pharmaceuticals
Founded in Sweden, with its long tradition of industrial entrepreneurship, Bluefish Pharmaceuticals has become
one of the most progressive generics pharmaceuticals companies. At Bluefish, we strive to make quality medicine
accessible to more people.
Bluefish creates value in the full pharmaceutical value chain from developing to manufacturing and successfully
marketing generic pharmaceuticals and we take pride in doing this in an innovative, responsible and cost-efficient
way. Bluefish currently conducts operations in 19 countries in Europe and, over the next few years, will also expand
outside Europe with the aim of becoming a global player.Our corporate culture and close collaboration with
development and manufacturing partners are integral parts of our effort to deliver quality products at affordable
prices.
We offer a product portfolio consisting of a broad range of high-quality generics for all major therapeutic areas. It
is part of our long-term strategy to expand the product portfolio of off-patent blockbusters while at the same time
offering a broader range of niche products within more narrow disease areas.
Bluefish products all originate from a generic substance, where the efficacy and safety are well documented.
Through our many collaborating partners, we have access to a vast range of technology platforms, enabling us to
develop and enhance the intellectual property of our product portfolio.
Our strategy of developing products based on well-known substances with an improved value to patients results
in a product portfolio with a significant market potential. We achieve this with a relatively short development time,
low risk, and limited investment.
By focusing on innovation and simplicity in both thought and action, and by taking responsibility on all markets and
cost efficiency in all stages, we are creating a strong and vibrant brand that offers quality pharmaceuticals at prices
affordable to all.
Bluefish provides quality generic pharmaceuticals at affordable prices. Its product portfolio contains a wide range
of products within all major therapeutic areas.
Since its inception, Bluefish has developed the platform and know-how to participate in and to be an integral part
of all major steps of the value chain in the offering of generic pharmaceuticals. With the vision of offering quality
pharmaceuticals at prices affordable to all, we have to be innovative and at the same time cost-efficient in all
stages. This includes operational excellence in departments such as product development, quality assurance,
pharmacovigilance, IP and supply chain as well as marketing and sales.
Profile Description
Bluefish is looking for profiles to fill the position of Senior Executive - Quality Assurance, contributing to the
accomplishment of the QA Department function objectives. The position will report to Senior Manager-Quality
Assurance. The role would be involved in the below mentioned areas:
- Review of executed Oral Solid Formulation BMR & BPR from various Supplier sites
- Reviewed Master Documents such as BMR and Spec and MOA against the change control and dossier
- Review of supplier change controls, incidents, OOS and deviations in executed batches.
- Follow up with Suppliers to ensure to get the corrected documents (if any) during review process.
- Ensuring Batches are executed as per European requirements and guidelines.
- Preparation of Product Quality Review as per European requirements,
- Review and approval of supplier PQR’s
- Escalate if any non-compliance observed in the Process at Supplier or at Bluefish
- Handling of Market compliant and aware about Pharmacovigilance activity
- Requesting Batch records and other documents with Suppliers
- Follow Bluefish Quality Systems and Management directions
Candidate Specifications
Education and Experience
- Bachelor’s Degree in any life sciences or Pharmaceutical sciences
- 4 to 6 years of experience in production or quality assurance environment in pharma industry
- Excellent computer skills, including Word and Excel in a Microsoft Windows environment
- Excellent interpersonal skills
Skills & Abilities Requirements
- Must have good communication skills
- Safety of the workforce
- Personal development thru’ self-learning
Email:hr@bluefishpharma.com
