I am looking for a meticulous and experienced SOP Writer to create and maintain Standard Operating Procedures for our pharmaceutical manufacturing operations. The ideal candidate should possess a strong knowledge of pharmaceutical industry regulations, such as GMP, FDA 21 CFR Part 211, and EU GMP Annex 15, along with industry best practices. A primary responsibility will be the development and revision of SOPs covering chapters 1 through 9 of GMP guidelines volume 4, including Annexes 1 to 21.
The final deliverable of the project will be SOPs that fully comply with chapters 1 through 9 of Eudralex Volume 4, including all independent topics covered within each chapter.
Chapter 4 Site Master File Generation and Control of Documentation Good Documentation Practices & Retention of Documents - Validation and qualification of processes, equipment and systems; - Equipment assembly and calibration; - Technology transfer; - Maintenance, cleaning and sanitation; - Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training. - Environmental monitoring; - Pest control; - Complaints; - Recalls; - Returns; - Change control; - Investigations into deviations and non-conformances; - Internal quality/GMP compliance audits; ( Audit System (Internal/External) Vendor Management - Summaries of records where appropriate (e.g. product quality review); - Supplier audits.
Chapter 5 Validation Product shortage due to manufacturing constraints
Chapter 6 Sampling Validation of testing Methods On-going stability programme Technical transfer of testing methods
Chapter 7 Quality Agreements QA & GDP
Chapter 8 Complaints Procedures for handling and investigating complaints including possible quality defects Product Recalls and other potential risk-reducing actions
Chapter 9 Self inspection
Responsibilities:
Develop / write SOPs in accordance with company standards and regulatory requirements. 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. 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.
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