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Required! Technical Writer – Pharmaceutical Batch Records
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Technical Writer – Pharmaceutical Batch Records

About the Job

Our Client – a global company with around 2,000 people in 14 locations worldwide is looking for a Technical Writer – Pharmaceuticalat their NJ headquarters location. Excellent Salary


Job Posting # 1616


Job Title:Technical WriterPharmaceutical Batch Records                 


Location:  Mahwah, NJ                        Relocation: No – Prefer local only


Compensation:Salary $70K-$90K     Benefits: Full package including medical, dental, vision, etc.


Job Description


Create, manage and oversee the generation of technical documents in support of Pharmaceutical Development, Operations and Equipment Qualification activities for the Pharmaceutical Services Division.


Job duties will include but are not limited to:


1.      Interact with technical associates/leads from other departments and divisions to create development and GMP Batch Records, Protocols, IQ/OQ/PQ documents, facility commissioning documents, investigations, CAPAs, change controls, product development reports, scale up documents, etc. with a strong emphasis on the following pharmaceutical processes (fluid bed granulation, blending, milling, compression, encapsulation, coating & packaging.  .


2.      Oversee and own the responsibility and the control of document templates to assure they are maintained, consistent across processes and updated to assure cGMP standards for Batch Records, protocols, and all IQ/OQ/PQ templates that are user friendly, clear, remove redundancies and improve compliance. 


3.      Support the department Director for process and equipment validation activities for site. 


4.      Prepare, write, update and maintain divisional/departmental SOPs where applicable, including the preparation of any forms or attachments that may accompany the SOP.


  1. Ability to research and understand the new equipment through user manuals to create IQ/OQ/PQ documents for equipment qualification program.


Candidate Requirements:


  • Degree in a Technical discipline with 3-7 yearstechnical writing experience in the pharmaceutical industry.
  • 7 – 10 years of technical writing experience to compensate for no Degree
  • Pharmaceutical Manufacturing/Development and cGMP background in a solid dosage form environment with preferred background in fluid bed processing with a clear understanding of compliance, clear, well defined processing steps, logical process flow and an emphasis on Quality processing
  • Ability to understand the fundamental processing stages required to create the initial batch records as well as other supporting documentation (i.e. protocols, change controls, investigations, deviations and final reports). 
  • Experience in writing GMP Batch Records, Protocols, IQ/OQ/PQ documents, investigations, CAPAs, change controls, deviations.
  • Excellent written and verbal communication skills with strong command of English.   
  • Detail oriented with solid organizational skillswith the ability to organize and track several projects simultaneously.    
  • Ability to communicate effectively with technical resources and follow up with multiple departments.
  • Strong computer skills


Keyword: validation, documentation, batch records, IQ, OQ, PQ, SOP’s, deviations, documents,technical, process, writer, pharmaceutical, FDA, editing, solid dosage, fluid bed

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