QA Specialist At Orchidia Pharmaceutical
Orchidia Pharmaceutical is looking for talented (QA Documentation Specialist)
Job Description
Issue, maintain, and design SOPs concerning the quality assurance department or other departments with common interfaces.
Prepare and implement quality policies.
Responsible for document control and record control activities.
Issuing and distributing controlled documents and withdrawing the obsolete and invalid versions including approved procedures and SOPs, specifications, methods of analysis, batch records, protocols and plans.
Perform all the required document updates for GMP documents for all departments.
Prepare the list of the approved documents and preparing the document status on regular basis.
Perform change control activities include assigning tracking numbers, routing, tracking, expediting change control, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
Participate in the implementation of the quality coding system.
Follow up change control actions on the computerized system.
Review specs (raw materials, primary, secondary packaging from quality control to release).
Issue and create batch manufacturing records and batch packaging records.
Assure all documents are reviewed for compliance with cGMP’s and company policies on periodic basis.
Participate in the internal and external audits.
Review and approve the specification of (raw material, primary packaging and secondary packaging and FP).
Apply statistical process control tools for the data collected with the purpose of continual improvement.
Collect data and apply statistical process control tools to prepare PQR (product quality review) for every product.
Collect all department data related to SMF (site master file) from the machine list and utility list and QC machine list and organization charts and which are used in production, quality control, research and development, engineering and quality assurance.
Review and approve the layout of the manufacturing and store and administrator site.
Collect all department data related to quality manual or IMS (integrated management system) which matches with ISO standards.
Issue and create media fill batch record and reviewing it with the batch manufacturing record to insure the media fill batch record mimics batch manufacturing in the process.
Responsible for recall procedure investigation and to design of recall and inform all related destinations and make reconciliation and follow up the recalled quantity.
Responsible for mock recall to mimic the actual recall.
Responsible for receiving the complaint and investigating it and detecting root cause and putting corrective and preventive action.
Receive the BOM of the packaging materials from the planning department to be checked for the correctness of the item codes.
Participate in the documentation cycle of the validation activities.
Responsible for following up on cGMP updates from different guidelines and reflecting them into the system in place by doing a gap analysis.
Follow up, maintain and ensure implementation of safety instructions and requirements in certain areas.
Work according to GLP, GMP and GDP rules.
Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
** Skills and Qualifications:
Bachelor’s degree in pharmaceutical sciences or science.
From 1 to 3 years of experience in pharmaceutical industry and operations.
Understanding of methodologies and best quality assurance practices.
Knowledge of documentation reviews and requirements analysis.
Ability to troubleshooting and resolving complex issues effectively.
Ability to work well through others.
Ability to meet workloads and project deadlines.
Excellent English, verbal / written communication.
Excellent computer skills.