Ideal Candidate
• 2+ years of Quality Assurance/ Quality Management experience
• 2+ years of experience working with GMP/ GDP in a pharmaceutical manufacturing
• Bachelor’s, or higher, degree in a scientific discipline, preferable pharmacy, biology or chemistry
• Strong interpersonal and attention to detail skills
• Excellent writing/communication skills
• English – advanced level
Job Description
o Assess and qualify new suppliers/ vendors in accordance with GMP and company standards.
o Plan the annual external audit plan for suppliers/ vendors
o Plan, conduct, and document supplier audits to evaluate compliance with quality and regulatory requirements.
Supplier Management:
o Maintain and update the Approved Supplier List (ASL) and related documentation.
o Develop and manage quality agreements with suppliers to ensure mutual understanding of quality expectations and responsibilities.
o Monitor supplier performance through regular evaluations and key performance indicators (KPIs).
Quality Oversight:
o Review and approve supplier-related documentation, such as Certificates of Analysis (CoAs), material specifications, and validation reports.
o Manage deviations, non-conformances, and complaints related to supplier materials and services, ensuring timely resolution and root cause analysis.
o Ensure compliance with GMP and regulatory requirements throughout the supplier lifecycle.
Risk Assessment:
o Perform risk assessments related to supplier quality issues and their potential impact on the manufacturing process and product quality.
o Identify and mitigate risks within the supply chain through proactive measures.
Collaboration & Communication:
o Serve as the primary point of contact for suppliers on quality-related matters.
o Collaborate with internal departments (e.g., procurement, production, QA, and R&D) to address supplier-related issues.
o Support regulatory inspections and audits by providing supplier-related documentation and responses.
Continuous Improvement:
o Identify opportunities for process improvements in supplier quality management.
o Participate in cross-functional projects to enhance supplier quality systems.
Quality Assurance:
• Participate in the implementation and improvement of the Quality System and Integrated Management in the company according to the Guide of Good Manufacturing Practice for medicines for human use (GMP), and the ISO standards
• Perform internal and external audits as assigned
• Assist with writing, revising, and approving standard operating procedures
• Perform various risk assessments
• Elaborate quality agreements
Company Description
Din 2001, suntem o companie farmaceutică solidă, cu o dezvoltare armonioasă în domeniile pe care le abordăm: cercetare, producţie şi distribuţie. Misiunea noastră este să îmbunătățim sănătatea oamenilor oferind produse de calitate la prețuri accesibile, iar viziunea noastră este să devenim unul dintre cei mai puternici și de încredere producători de produse farmaceutice din România prin investiții în direcția extinderii și diversificării portofoliului de produse.
Deţinem una dintre cele mai moderne fabrici de produse farmaceutice, respectând regulile privind Bună Practică de Fabricaţie (GMP) pentru producţia şi distribuţia medicamentelor, cu laboratoare de cercetare de cel mai înalt nivel, linii de producţie moderne şi o puternică echipa de reprezentanţi medicali şi de vânzări, ne numărăm printre principalii competitori autohtoni de pe piaţa farmaceutică din România.
Portofoliul nostru depășește 100 de produse (medicamente cu prescripţie medicală, medicamente fără prescripţie medicală - otc-uri şi suplimente alimentare), iar proiectele noastre urmăresc extinderea gamei de produse anual atât pe piață din România, dar și pentru piață externă și sunt susținute de investiţii concentrate spre îmbunătăţirea produselor și serviciilor noastre, având că principal obiectiv satisfacţia consumatorilor şi susţinerea unei vieţi sănătoase.
