Micro Labs Limited is a multi-faceted healthcare organization with a proficient marketing team, state-of-the-art manufacturing facilities and R&D centres that are at par with international standards. All this, robustly backed by a strong distribution network and path-breaking research work has placed us amongst India’s fast growing transnational healthcare organizations.
Post : Sr. Executive/Asst Manager-Ophthalmic / Sterile products (FR&D)
Experience: 3-6 Years
Qualification: Master in Pharmacy
Role & Responsibilities:
• Media preparation and evaluation.
• Literature survey. Grade and source of APIs and Excipients selection. Indent of Innovator samples.
• Pre-formulation studies and formulation trials leading to indentifying a suitable composition for the product.
• Experiments planning in coordination with analytical team.
• Selection of mode of sterilization and filters.
• Selection and finalization of Container closure system.
• Preparation of scale-up batch record and Process evaluation protocols for execution of process evaluation batches at plant level.
• Preparing and reviewing of technology transfer documents for pilot/exhibit batches and commercial scale manufacture.
• Providing technical support during exhibit batches as and when required.
• Interaction with cross functional teams such as IPR. Regulatory. Quality Assurance etc.
• Preparation of technical regulatory documentation to support development work and manufacturing (includes protocols, reports, laboratory note books and batch records) to internal, customer, regulated and semi regulatory requirements.
• Preparation of Product Development Report as per QbD and Preparation of QBR for regulatory filing. Identifying the area and preparation of standard operating procedures.
Additional Information
Experience : 3-6 years
Qualification : M.Pharm
Location : Bangalore
Industry Type : Pharma
Functional Area : FR&D
Share your Resume Email: hrkudulu@microlabs.in
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