Reporting to the Production Managers, the Technical Writer/Associate will effectively draft and create technical reports like investigation reports, change control requests supporting changes wherever required, SOPs, and any other documentation as deemed necessary by QA. The Technical Writer/Associate must ensure that these reports are drafted in consultation of the relevant department in accordance with all applicable internal SOPs and procedures while equally ensuring that the data is reliable. It will also be their responsibility to assist and manage these reports in line with the applicable SOPs and time lines to ensure compliance.
Candidates must be educated to degree level or the equivalent in a relevant scientific or healthcare discipline. They must possess previous proven experience of working within a generic or branded pharmaceutical company and should be able to demonstrate an understanding of cGMP guidelines, global regulatory guidelines, and the basics of pharma process technology. The Technical Writer must also possess the ability to work and plan independently and communicate effectively as part of a team, thus excellent interpersonal skills are essential. The successful candidate must display a flexible attitude in their approach to the role as the position involves extensive interaction with many departments within the organization.
Requirements
Bachelor's degree from a four-year college or university
3-5 years experience writing/developing SOP/Procedural documentation
Previous job experience in a pharmaceutical industry and/or a pharmaceutical manufacturing environment is highly desirable
Knowledgeable in manufacturing processes
Exemplary analytical ability and technical writing skills. Should know how to produce effective written correspondence
Excellent communication skills. Know how to organize and deliver information based on the message. Understand how to structure reports. Understand the innate structures of English grammar
Strong product/technology/industry knowledge. Validation experience in preferred.
Understand the mandated for documentation set forth by regulators such as the FDA, EMEA, and other governing bodies.
Understand how documents work in tandem from initial correspondence about a report to an approved protocol, amendments, and final study report. Perform technical review of batch records and other relevant documents for accuracy, completion, and compliance to cGMPs.