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Quality Assurance Manager - Pharmaceutical
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Quality Assurance Ma....
drjobs Quality Assurance Manager - Pharmaceutical العربية

Quality Assurance Manager - Pharmaceutical

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1 Vacancy
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Jobs by Experience

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10 - 15 years

Job Location

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Cairo - Egypt

Monthly Salary

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EGP 4000 - 6000

Nationality

Egyptian

Gender

N/A

Vacancy

1 Vacancy

Job Description

Req ID : 1107449

A. Essential Duties and Responsibilities:

  • Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
  • Responsible for setting strategy direction for the Quality Assurance Dept. and team
  • Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support (if any)
  • Support team by guidance and coaching and provide direction/approval of activities and decisions
  • Cultivate and reinforce appropriate group values, ethics, norms, and behaviors
  • Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews
  • Ensure proper use of assets, budget, and personneland communicate effectively with key customers and partners, both within the site and outside as appropriate
  • Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls (including SOPs and master batch records)
  • Conduct impact assess to design changes and participate/coordinate CAPA Review Board
  • Maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations
  • Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems
  • Actively with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues
  • Coordinate planned and/or ad-hoc external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan
  • Responsible for driving cross-training across Drug Substance, Drug Product, Site staff resources (as well as potentially other areas of QA)
  • Work directly with internal and external customers to assure Best-in-Class expectations for quality are met if not exceeded
  • Analyze trends, quality metrics and other data to identify quality and compliance gaps
  • Participates in the recruitment, selection, promotion, and performance management of QA employees

Job Requirements

B. Qualification/Knowledge/Experience:

Level of Education:

  • Pharmacygraduate preferably with related post-graduate QMS degree or

Experience :

  • Track record of leading the QA function at sound pharmaceutical organizations

Language:

  • Excellent verbal, written and interpersonal communication skills. English fluency essential

IT Literacy :

  • MS-Office

C. Competencies and Behaviors:

  • Previous experience mentoring and coaching experienced Quality professionals
  • Proven results using quality improvement tools and techniques to drive improvements across different functions at Multicare's Site
  • Leading by example to be role model for others
  • Collaborative approach and ability to build strong partnerships with cross-functional teams to drive results
  • Demonstrate excellent communication, facilitation, and conflict resolution skills
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic
  • Excellent written and verbal skills in English
  • Project Management experience and/or certification is a definite plus

Employment Type

Full Time

Company Industry

Pharma / Biotech / Clinical Research

Department / Functional Area

Quality / Testing / QA / QC / Inspector

Key Skills

About Company

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