My client is a renowned specialty generic pharmaceutical company, ranking in the top five largest in the world. Their global revenues exceed US$ 4.9 billion, a testament to their significant market presence and success. Backed by a vast network of over 38 state-of-the-art manufacturing facilities, they are dedicated to producing top-notch medicines. Their commitment lies in providing high-quality and cost-effective pharmaceutical products, earning the trust of both healthcare professionals and patients worldwide. With a robust distribution network, their medicines reach and benefit more than 100 countries across the globe.
The primary responsibilities encompassed in this role involve the composition of technical documents, including analytical methods, specifications, validation protocols, validation reports, transfer protocols, and standard operating procedures (SOPs) in adherence to the company's established standards and in accordance with FDA/ICH guidelines. Additionally, the incumbent is required to diligently assess updates to the United States Pharmacopeia (USP) and promptly revise pertinent documents to incorporate these changes effectively.
- Supervise the creation process of method/specification and Laboratory Standard Operating Procedures (SOPs).
- Compose, review, and approve technical documents, including methods, specifications, validation protocols, validation reports, transfer protocols, and SOPs. Ensure compliance with corporate policies, compendia requirements, and guidelines from ICH and FDA.
- Initiate and review change controls for method/specification and SOP revisions, ensuring timely closure of these controls.
- Facilitate communication to cross-functional teams regarding changes in specifications and methods.
- Evaluate specification and method changes carried out by vendors, ensuring their proper implementation.
- Share specifications and methods with cross-functional teams for review and approval.
- Execute actions assigned as part of Corrective and Preventive Actions (CAPA).
- Manage the master copies of methods and specifications.
- Issue controlled copies to Quality Control (QC) for use, maintain appropriate documentation, and archive retired copies properly.
- Evaluate compendia documents and review procedures for analytical development and validation.
- Possess a good understanding of ICH and FDA regulatory guidance to prepare documents accurately.
- Assign document numbers and maintain both hard copies and electronic files of technical documents.
- Liaise with raw material manufacturers for any required technical information.
- Provide timely submission of documents required for Changes Being Effected (CBE), Prior Approval Supplement (PAS), and Abbreviated New Drug Application (ANDA) to the Regulatory Affairs (RA) department.
- Minimum requirement of a Bachelor's degree (B.S.) in a scientific field.
- Minimum eight (8) years of experience in pharmaceutical analytical laboratory along with technical writing
- Previous experience as a chemist, with hands-on expertise in conducting wet chemistry analysis and proficiency in operating analytical instruments such as HPLC, GC, dissolution, etc.
- Proficient in computer skills, including Microsoft Office applications (Word, Excel, PowerPoint) and Access.
- Strong written and verbal communication skills.
- Familiarity with TrackWise, LIMS, and Document Management System, demonstrated through practical experience.
- Excellent project management and problem-solving capabilities.
- Ability to work independently without close supervision.
- Thorough understanding of FDA and DEA regulations.
- Knowledgeable in proper cGMP practices applicable to analytical laboratories, and skilled in basic laboratory instrumental analysis and wet chemistry techniques.
- Collaborates effectively with colleagues and external partners to achieve primary departmental objectives.
- Ensures adherence to cGMPs, DEA regulations, safety protocols, and site operating procedures, under the guidance of management.
- Works in alignment with project plans and objectives as assigned by management.
- English language proficiency requirement for this role is at the Intermediate-B1+ level (comparable to Global CEFR Independent B1) based on the Common European Framework of Reference for Languages (CEFR).