Assistant Manager-Quality Assurance-Audits And Technical Agreements

8-12 years

Not Disclosed

Bangalore

10 Dec. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Assistant Manager - Quality Assurance - Audits and Technical Agreements
Location: Bluefish Pharmaceuticals
Job Category: Quality Assurance

About Bluefish Pharmaceuticals:

Founded in Sweden, Bluefish Pharmaceuticals has become one of the most progressive generics pharmaceutical companies. We strive to make high-quality medicines accessible to more people worldwide. Bluefish is committed to innovation, cost-efficiency, and delivering affordable, high-quality generic pharmaceuticals. We operate in 19 countries in Europe and plan to expand globally, with a focus on developing a strong portfolio of off-patent blockbusters and niche products in specialized disease areas. Our collaboration with development and manufacturing partners is key to our success.

Role Overview:

Bluefish is seeking an Assistant Manager - Quality Assurance - Audits and Technical Agreements to contribute to the achievement of the QA function objectives. The position will report to the Senior Manager and involve internal and external audits, technical agreement negotiations, and ensuring compliance with GMP standards. You will also be responsible for ensuring the quality of third-party vendors and overseeing the product launch process.

Key Responsibilities:

Internal and External Audits: Schedule, prepare, conduct, document, and follow up on Corrective and Preventive Actions (CAPA) for GxP audits.
Stakeholder Communication: Communicate audit observations and GMP deficiencies to relevant stakeholders, assessing their impact on product quality and compliance.
Regulatory Compliance: Monitor regulatory non-conformance reports, analyze their impact, and ensure compliance with Bluefish’s standards.
Supplier Audits: Review third-party audit reports from CMOs and outsourced agencies for compliance with Bluefish and regulatory requirements.
Risk Assessment: Conduct risk assessments for audit processes, evaluate suppliers, and finalize annual audit schedules.
Product Launch Support: Actively participate in the product launch process, ensuring all QA-related prerequisites are met.
Training: Lead internal/external GMP training and support new auditing staff training.
Technical Agreements: Draft and negotiate technical agreements with suppliers, ensuring compliance with quality standards.
Technology Transfer: Represent QA during the technology transfer process, reviewing documents and specifications.
KPI Achievement: Meet key performance indicators related to audits, agreements, and compliance.
Process Improvement: Identify and drive continuous improvements in quality auditing processes.

Candidate Specifications:

Education & Experience:

Must-Haves:
- 8-12 years of professional experience, with at least 5 years in a lead auditor role (GMP/GDP) for domestic and international audits.
- Lead Auditor certification from a reputable EU certification agency (e.g., ECA, PQS-CQI-IRCA, NSF).
- Expertise in drafting and negotiating Quality/Technical Agreements with GMP/GDP suppliers.
Other Requirements:
- Graduate/Postgraduate degree in life sciences or pharmaceutical sciences.
- Strong interpersonal and computer skills (MS Office).
- Solid understanding of EuGMP, ICH, and global regulations (EU, PICs, EMA, ISO, WHO).

Skills & Abilities:

Excellent communication skills.
Strong personal development through self-learning.
Advanced knowledge of pharmaceutical quality systems and international regulations.
Ability to use qualitative/quantitative data for decision-making.
Commitment to workforce safety and quality standards.

Apply Now:

Interested candidates can send their resumes to hr@bluefishpharma.com. For more information, please visit Bluefish Pharmaceuticals Website.

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Assistant Manager-Quality Assurance-Audits And Technical Agreements

Job Description

About Bluefish Pharmaceuticals:

Role Overview:

Key Responsibilities:

Candidate Specifications:

Apply Now:

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