QA Vacancy At Nerhadou International
QA documentation Sr. officer At Nerhadou International
Quality Assurance Documentation senior will be responsible for assisting in the implementation and maintenance of the Quality Management System (QMS) by coordinating the revision, review, and approval of Batch Manufacturing Record (BMR), Batch Packaging Report (BPR), SOPs and other GMP documents ensuring compliance with applicable domestic standards and regulations.
Preparation for external audits and Follow audit findings investigation.
Vendor qualification and conducting vendor audits.
Document and record control.
Issuance and reviewing of QA documents.
Revision of batch records, certificate of analysis, method of analysis, specifications, etc…
RESPONSIBILITIES AND TASKS:
Develop procedures to ensure that Quality System documents are originated, changed, reviewed, distributed, archived and periodically reviewed using systems that are efficient and meet all regulatory requirements.
Develop and maintain systems that effectively archive and retrieve quality records assigned to the Document Control, including external standards, technical reports, etc.
Ensure that the Document Control systems used at all company sites are harmonized where appropriate.
Updates and maintains Quality Assurance Operations logs and databases and generating metrics as needed.
Follow up the registration requirements (samples, certificates, specifications, methods of analysis) for the registration department.
Creation, update & issue batch records required for production – Filling & Packaging.
Prepare periodic summaries of document and record control activities, including the analysis of the types of changed documents, change order cycle times.
Responsible for Preparation, Review, Control and Revision of Standard Operating Procedure.
Preparation, Review and Control of Formats and all documents.
Responsible for training program.
Responsible for Preparation, Review, Control and Revision of head files Like (Site Master File, Quality Manual).
Responsible for Preparation, Review, Control and Revision of Analysis Worksheets.
Responsible for Preparation, Review, Approval, Control and Revision of Specifications and Standard Test Procedures.
Participates in internal audits and supporting external audits
Responsible for Batch Release process.
Responsible for reconciliation of documents.
Responsible for batch record revision after retrieval from production.
Education: Bachelor of pharmacy or science.
Experience:(3-5) year of experience.
Skills: Computer knowledge, English language is good, good in Microsoft excel & word and soft skills
Interested applicants should send their CV to Job@nerhadou.com and mention the position subject line.