Quality Assurance Specialist İş İlanları

QUALIFICATIONS AND JOB DESCRIPTION

About Biocodex

Biocodex is a French family-owned pharmaceutical company headquartered in Gentilly, near Paris, France. The company was founded in 1953 to develop and market the world’s first probiotic yeast strain, Saccharomyces boulardii CNCM I-745, discovered in 1923. Since then, Biocodex has evolved from a pioneer to a major international player in the microbiota realm.

Qualifications

· BSc Pharmacy, Chemistry, Chemical Engineering preferred,

· Preferably 5+ years of experience in the Pharmaceutical Industry in the area Quality/Regulatory affairs or equivalent experience/knowledge of regulatory requirements and applicable quality standards,

· Hands-on experience in the application of pharmaceutical Quality Systems and Quality Assurance including solid knowledge of EU GDP, cGMP, ICH, local regulations and other applicable quality guidelines and standards, and an ability to interpret and apply them effectively,

· Previous experience as a Quality Responsible Person/Responsible Manager in the pharmaceutical industry with solid quality and compliance expertise and direct experience interacting and effectively communicating with Health Authorities and managing Health Authority inspections,

· Must be fluent in English, both spoken and written,

· Competent in scientific problem solving and risk analysis capabilities,

· Strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation,

· Demonstrates organizational skills, is proactive and self-motivated with ability to multi-task. Some level of contractual and financial awareness is preferred.

Job Description

· Responsible for local batch release to the market operations,

· Ensure correct storage conditions are applied and monitored,

· Warehousing and inventory management,

· Product Quality:

· Ensure effective management of Product Quality Complaints (PQCs) including routing the PQCs and samples to the manufacturing site/MAH,

· Tracking, trending or signaling of distribution complaints,

· Coordination of Customer Temperature excursion assessment.

· Returned Goods Management,

· Information and interaction with local business and regional Quality Management,

· Ensure Quality perspective is brought into local business initiatives with Quality impact.

· Metrics/ Regulatory Compliance:

· Ensure preparation of Quality Metrics (e.g. deviations, inspection outcomes, CAPAs),

· Present Quality Metrics to stakeholders (e.g. management, Quality Compliance Council),

· Oversee and Track Quality Improvement Actions.

· Deviations:

· Deviation management, overview and tracking,

· Management of CAPAs, including tracking,

· Ensure handling of temperature excursions during transport, warehousing and distribution.

· Audits & Self-Inspections

Benzer İş İlanları