Document Control Specialist
Posting ID: JP-002663833
1. Compose and review technical documentations such as technical reports, development reports, risk assessments, DOE protocol/reports, process validation protocol/reports. 2. Provide support to Regulatory Department to prepare CMCs. 3. Supporting all activities related to Document Control in GMP Manufacturing. 4. Controlled document preparation, routing and issuance, supporting Document Creation/Change system. 5. Issuing controlled copies of released documents (forms, procedures, production batch records etc.) to manufacturing department upon request. 6. Reviewing GMP notebooks and logs prior to submitting to Quality Assurance for archiving. 7. Reviewing all scientific and technical data on Production Batch Records after GMP production. 8. Obtain corrections on documents from GMP personnel in the laboratories and office area. 9. Complete and submit all required documents to Quality Assurance for drug substance release. 10. Supporting Management during regulatory agency and customer audits and visits. 11. Represent PolyPeptide Group with a high level of integrity and professionalism. 12. Adhere to PolyPeptide Group policies and support Management decisions in a positive, professional manner. 13. Other manufacturing document control related tasks as applicable. 1. Organizing and maintaining all GMP documents (i.e. Production Batch Records, notebooks, logbooks and forms) in the GMP laboratories and office area.
Doc Control, QA, gmp environment, batch record, GMP, Reporting, technical report writing
Top Skills Details:
Doc Control,QA,gmp environment,batch record
Additional Skills & Qualifications:
1. Ability to work within the PPL safety guidelines. 2. Good written and oral communication skills; ability to communicate effectively and project a professional image when giving and taking information in writing, in person, and over the phone. 3. Accurate typing/keyboarding skills; solid computer skills, including the use of word processing and spreadsheet software applications. 4. Ability to take initiative and prioritize tasks; good time-management, problem prevention, and problem-solving skills. 5. Knowledge of cGMP, specifically, ICH Q7. 6. Sufficient technical background and understanding to review Production Batch Records and other GMP documents. 7. Ability to work independently and as part of a team; ability to motivate self. 8. Ability to work accurately with close attention to detail. 9. Ability to maintain confidentiality of sensitive information. 10. Ability to work with co-workers, customers/clients and outside agencies professionally and tactfully. 1. Associates degree as a minimum; Bachelor's degree in Chemistry or Biochemistry preferred. 2. One year experience in a regulated industry as a minimum. 3. GMP laboratory and documentation experience preferred. 4. Experience in scientific technical writing preferred, but not required.
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Recruiter: Jennifer Martin