Pharmaceutical SOP Writer Needed

Job ID: 39508792

Budget: €8 – €30 EUR

I am seeking a detail-oriented and experienced SOP Writer to develop and maintain Standard Operating Procedures (SOPs) for our pharmaceutical manufacturing processes. The ideal candidate will have a strong understanding of pharmaceutical industry regulations (e.g., GMP, FDA 21 CFR Part 211, EU GMP Annex 15) and best practices. A key area of focus will be creating and updating SOPs related to chapter 1 to chapter 9 of GMP guidelines volume 4.

Responsibilities:

Develop, write, and revise SOPs in accordance with company standards and regulatory requirements.

Collaborate with subject matter experts (SMEs) to ensure SOPs are accurate, comprehensive, and reflect current processes.

Create and maintain SOPs related to change control, including procedures for initiating, evaluating, implementing, and documenting changes to processes, equipment, and systems.

Ensure that SOPs are clear, concise, and easy to understand by all personnel.

Incorporate visual aids such as flowcharts and diagrams to enhance clarity.

Manage the SOP review and approval process, including obtaining input from relevant stakeholders.

Ensure that SOPs are properly implemented and that personnel are trained on the procedures.

Maintain SOP documentation and ensure that all documents are properly controlled and archived.

Conduct periodic reviews of SOPs to ensure they remain current and effective.

Identify opportunities to improve SOPs and streamline processes.