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Manufacturing Specialist III, Mfg Tech Ops

3.00 to 5.00 Years   Chennai, Hyderabad, Kolkata   06 Apr, 2022
ONQANET TECHNOLOGIES PVT LTD
Job LocationChennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedia / Dotcom / Entertainment
Functional AreaTechnical / Process Training
EmploymentTypeFull-time

Job Description

    In the Manufacturing Specialist role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.What You ll Do:
    • Act as subject matter expert authoring manufacturing documentation including batch production records, solution lot records, procedures, and work instructions and deliver on key stakeholder requirements.
    • Support the technology transfer of products into manufacturing and communicate across functional teams ensuring production schedules are met.
    • Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions
    • Utilize depth of experience to lead manufacturing projects, establishing new processes and resolving complex technical problems.
    • Proactively engage with cross functional groups (e.g., Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, and Materials Management) to identify continuous improvement opportunities and drive implementation.
    • This on-campus, site-based role supports Manufacturing (MFG) - primarily during core weekday business hours but may require infrequent off-hours support.
    Who You Are: If you are a highly detailed and focused individual who demonstrates a high level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.Required Skills:
    • Extensive experience in manufacturing antisense oligonucleotide synthesis, oral solid dose manufacture, or parenteral filling operations preferred
    • Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
    • Robust understanding of quality and cGMP principles
    • Advanced knowledge of change control in cGMP environment
    • Intermediate to advanced skills in Microsoft Office and computer-based quality systems
    • Advanced level of technical writing skill
    • Ability to interpret manufacturing process design documentation
    • Excellent oral and written communication skills
    ,

Keyskills :
subject matter expertisecontinuous improvement facilitationprocess designwriting skillschange controlmicrosoft officetechnical writingtechnical processwork instructions

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