Supervising quality assurance documentation and compliance personnel,
preparing and participating in the quality assurance activities including; SOP
and specification revision, deviations, change controls, release process,
rejection process, annual product quality review, batch record drafting and
preparation, batch record issuing, customer complaint and supplier
qualification, site master file, quality manual, export cycle revision,
internal audit, media fill batch record issuing and creating, recall and mock
recall process.
Essential Tasks:
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.
Receive the BOM of the packaging materials from the planning department to be
checked for the correctness of the item codes.
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.
Participate in the documentation cycle of the validation activities.
Train newly hired employee properly ensuring their ability to perform all
types of tasks assigned efficiently and enhancing their skills in accordance
to the approved standard.
Formulate and recommend technical training programs based on knowledge of
identified training needs, company production processes or changes in
products, procedures or services.
Follow up, maintain and ensure implementation of safety instructions and
requirements in certain areas.
Follow up, maintain and ensure implementation of GLP, GMP and GDP rules.
Shall be consulted and participated and enforce subordinates' implementation
in the EHS management system and its improvement elements via reporting
actions / incidents those could occur or occurred and attend the relevant
trainings.
Bachelor's degree in pharmaceutical sciences or science.
From 8 to 10 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.
Pharmaceutical science or Science
مكان الوظيفة
القاهرة, مصر
الدور الوظيفي
التصنيع
الحالة الوظيفية
دوام كامل
نوع التوظيف
موظف
يتطلب إدارة موظفين آخرين
نعم
عدد الوظائف الشاغرة
1
المستوى المهني
متوسط الخبرة
عدد سنوات الخبرة
الحد الأدنى: 8 الحد الأقصى: 10
منطقة الإقامة
القاهرة, مصر
الجنس
ذكر
الجنسية
مصر
الشهادة
بكالوريوس