Home Jobs in Saudi Arabia Quality Responsible Person ( Temp: 1 Year)

Quality Responsible Person ( Temp: 1 Year)

Pfizer Inc

Posted on January 14, 2020

3 - 4 years Saudi Arabia - Saudi Arabia

Bachelor of Pharmacy(Pharmacy). Any Nationality

Opening 01

Job Description

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Job Specific Technical / Functional / Professional Competencies:
• Responsible for thorough batch record review of different solid dosage form processes (i.e. Manufacturing, primary packaging and secondary packaging).
• Review corresponding documentation to support the timely disposition of product.
• Coordinating release priorities with other departments.
• Ensure Release section KPIs and cycle time are met.
• Preparing and maintain required SOPs and ensuring that these procedures are strictly followed during release process.
• Ensure adherence to Data integrity requirements in final documentation review process.
• Support in Internal Auditing run on other functions.
• Complete/ follow up on QTS records CCR, RAAC, LIR or QARs impacting release.
• Act as back up for other QA section activities.
• Responsible for developing and maintaining of Batch Record Archiving system.
• Reviewing of finished products COA documents.
• Reporting and initiation of any major or critical incident observed during batch record review.
• Reviewing and approval the required SOPs related to Production operations and ensuring that these procedures are strictly followed during batches processing and documentation.
• Act as Quality assurance representative in the reviewing process of technology transfer plans (TPP).
• Coaching section colleagues with their improving projects and sponsoring their projects.
• Follow up applying of GMP rules during review of batch documentation.
• Register the disposition decision of FG good in ERP system (Enterprise 1).
• Review and approval of Master Batch Records.
• Release of finished goods on SCT (Serialization Control Tower) & SFDA DTTS (Drug Track & Trace System).
• Responsible for Quality oversight on Quality control department.
• Act as quality reviewer/ approver for different quality control lab investigations (RAAC, LIR or QAR).
• Essential member at QC internal audit team.
Experience and Knowledge:
• University Pharmacy degree.
• Valid license from SCHS with minimum 3 years as licensed Pharmacist
• Experienced in release of finished products to Saudi market and incoming material to production.
• Ability to read English and interpret documents such as cGMP/ SFDA regulations, standard operating procedures, and Pfizer corporate policy manuals.
• Experience in lab Equipment including but limited to HPLC, GC, UV, FTIR
• Experienced in data integrity principles
• Experienced in computer system access level and sign off requirement.
• Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
• Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
• Excellent attention to detail and time management skills.
• Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
Essential Personal Qualifications:
• Bachelor s degree of pharmacy.
• Minimum of 3 years in Quality assurance batch record review and disposition.
• Valid pharmaceutical specialty license as practitioner.
• Good command of English both written and spoken.
• Knowledgeable with interpersonal learning.
• Communication, teaching and coaching skills.
• Logic way of thinking with High analytical skills.
• Management and decision-making skills.
• Professional in reports writing.
• Has the ability to work under stress.
• PC literate with the following applications: MS Excel, Word, PowerPoint.


Pharma / Biotech / Clinical Research

Quality / Testing / QA / QC / Inspector

Keywords

Quality Responsible Person (Temp: 1 Year)

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