Minimum of 5-8 years’ experience in a GMP laboratory environment. At least 5 years’ experience in writing and reviewing standard operating procedures.
Experience with Veeva EDMS preferred, or similar.
Experience with ERP, SAP Preferred, revising or creating new documents.
Experience working cross functionally, communication and customer service skills.
Key Responsibilities and Major Duties
Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
Ability to interview cross functional subject matter experts and translate their description into actionable instructions.
Work Instructions, Job Aids using the templates prescribed by corporate policy.
Schedule cross functional team meetings, collect feedback, create draft documents, post on SharePoint, schedule reviews, collect and resolve feedback.
Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
Work independently but recognize need to consult stake holders and keep them informed of progress.
Identify and lead improvement efforts within current procedures.
Maintain a good understanding of ICH Guidelines, regulations and other guidelines applicable to GMPs.
Ability to negotiate and influence solutions without direct authority.
A self-starter with an ability to manage electronic systems with minimal training and supervision.
Requirements
Minimum of 5-8 years’ experience in a GMP laboratory environment. At least 5 years’ experience in writing and reviewing standard operating procedures.
Experience with Veeva EDMS preferred, or similar.
Experience with ERP, SAP Preferred, revising or creating new documents.
Experience with microbiology testing is a plus.
Demonstrated ability to successfully manage competing deadlines and balance priorities.
Excellent technical writing skills, close attention to detail and excellent follow up.
Expertise in Microsoft Word and Share Point.
Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
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