FDF Technical Support Specialist - Outsourced Mfg

Urgent Opening for FDF Technical Support Specialist - Outsourced Mfg

We are seeking a highly skilled Finished Formulation Tech specialist technology Transfer Specialist to join our team. This individual will be responsible for overseeing the technology transfer of pharmaceutical finished formulations to contract manufacturers (CMOs) for the export market. The ideal candidate will have experience with global pharmaceutical manufacturing, export regulations, and quality assurance processes.
Key Responsibilities:
Technical Support
Project Management
Technology Transfer Management:
o Collaborate with internal R&D and CMO teams to ensure the successful transfer of technology for commercial production.
o Oversee the tech transfer process, ensuring consistency in manufacturing performance and product quality.
o Conduct and review process validation, ensuring compliance with international regulatory requirements (FDA, EMA, etc.).
• CMO Relationship Management:
o Manage relationships with contract manufacturing organizations (CMOs) to ensure alignment on manufacturing timelines, quality standards, and regulatory compliance.
• International Regulatory & Supply chain management
o Oversee the export of pharmaceutical products to international markets, ensuring adherence to local regulations (such as GMP, GDP, import/export compliance).
o Ensure CMO's capability to meet market-specific regulatory requirements, quality assurance standards, and timelines.
• Quality Control & Compliance:
o Ensure CMO adherence to Good Manufacturing Practices (GMP) and other regulatory standards.
o Oversee the review and approval of batch records, deviation reports, and CAPAs.
o Conduct periodic audits and ensure compliance with export pharmaceutical guidelines in all involved territories.
• Continuous Improvement:
o Work with CMOs to optimize processes and reduce costs without compromising on quality.
Key Requirements:
• Education
o Bachelors or Masters degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.

o Minimum of 15 years of experience in pharmaceutical manufacturing, with a focus on technology transfer, contract manufacturing, and export markets.
o Knowledge of global regulatory requirements for pharmaceutical products, including FDA, EMA, ICH, GMP, and export guidelines.
• Skills:
o Excellent communication and interpersonal skills to manage relationships with CMOs and cross-functional teams.
• Experience in global markets, especially emerging markets for pharmaceutical exports

Location - Mumbai
salary open for right candidate
Experience 15+ in Tech specialist for Outsourcing / Technology Transfer Specialist
Interested candidate please mail me your cv at hr@archerchem.com or what's up on 9028871352.