Senior Executive

1 week ago

Ahmedabad, India LOXIM INDUSTRIES LIMITED Full time

Job Title: Senior Executive - Technology Transfer


Experience: 6+ Years


Industry: Pharma (API / Intermediates)


Location: Ahmedabad


Company: Loxim Industries Limited


Reports To: Vice President OPs


Company Overview:

Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have continually evolved and expanded in both scale and industry focus. From high-performance Dyes and Engineering Plastics to APIs, Intermediates, KSM, and CMO/CDMO Capabilities in the Pharmaceuticals industry, our diverse product range creates infinite possibilities for our stakeholders worldwide. We are headquartered in India, and our offices are strategically located in the USA, Singapore and Germany to ensure efficient service to our customers worldwide.


Why Join LOXIM?

·        Be part of a globally recognized company known for its commitment to innovation and excellence.

·        Work in a dynamic environment that encourages growth and continuous learning.

·        Collaborate with a team of experts and leverage your skills to drive meaningful change.


Position Overview:

We are looking for an experienced candidate for Tech Transfer Role who is willing to execute the experience in uplifting the process and can trouble shoot. Develop Tech Transfer Protocols.

Understand equipment mapping from Lab to Plant to Production, process feasibility, process flow, Solvent recyclability and achieve results as per GMP & Global FDA Standards.


Key Responsibilities:

·        Responsible for execution of Scale-up, Exhibit, Pre-validation, Process verification and Validation batches

·        To prepare, review and approve Change control, Temporary change, Deviations, OOS (Out of Specification), OOT (Out of Trend), Assessment report/s, Scale up report, justification report/s and other related documents

·        To review and approve master manufacturing records

·        To manufacture lab scale trial batches and process optimization trial batches in R&D

·        Co-ordinate with R&D, Production, Quality Assurance, Analytical R&D, Quality control for smooth transfer of Technology from exhibit batch to Production scale

·        To follow the standard operating procedures and safety precautions

·        Trouble shooting activities to be performed (if any) during the manufacturing of Plant validation batches, Process Verification / Process Validation / Commercial batches.

·        To support in activities related to costing i.e. (COGs) and new or any equipment installation and qualification purpose.

·        To evaluate feasibility changes in product life cycle management, prepare and approve gap analysis for site transfer batches and provide risk assessment for the same.

·        Design and develop technology transfer protocols and other protocols (Sampling, Stability and other related protocols ) for different dosage forms


Skills & Knowledge:

·        Strategic Planning

·        Commercial Acumen

·        Technology

·        Legal

·        Adaptability

·        Good Engineering Knowledge

·        Good Process Flow Ideas


Qualifications:

          Bachelor's in chemical engineering


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