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Quality Assurance/Laboratory Manager

Date Posted
9th August 2017
Reference
VAC-26566
Sector
Healthcare & Medical, Quality Assurance
Job Type
Temporary
Location
San Juan, PR
Salary
Not Disclosed

Job Summary

Coordinates/manages a team of multi-discipline professionals in areas of data analysis, document audits and inspections.

Job Description

Duties & Responsibilities:

  • Provides team with training, direction, motivation, guidance and performance evaluation to assure optimal group and individual task execution.
  • Expected to promote the expertise of individual team members as well as broaden their technical and process knowledge in the varied aspects of Products manufacturing and Quality Assurance.
  • Must be proficient in planning and coordinating projects relevant to product release and testings aligned to value stream. Develops/updates systems and policies on the aspects of product review and release.
  • Seeks opportunities for continuous improvement in the quality of products and develops action plans for their implementation. Anticipates upcoming regulatory issues, develops response plans and implements programs to establish industry standards.
  • Collaborates with internal and external technical and management personnel to establish priorities and release parameters for product release or market introduction and approve and monitor any contract analysts. Direct interaction with customer product implementation and transfer, Quality Agreements Audits and regulatory commitments.
  • Approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products.
  • Ensure that all necessary testing is carried out and the associated records evaluated.
  • Approve specifications, sampling instructions, test methods and other Quality Control procedures.
  • Ensure the qualification and maintenance of his department, premises and equipment. Responsible for implementing the Quality Assurance Strategies.
  • Ensure that the appropriate validations are done; and ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
  • Provides timely feedback and evaluates employee performance of direct reports after obtaining the relevant functional input and evaluation. Provides supervision and guidance to the first-line supervisors and through them, to the hourly personnel in a manner consistent with site policies and procedures to achieve business objectives.
  • Serves as a liaison with Professional and outside groups related to cGMP’s and Regulatory Complianc
  • Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
  • Perform any other job related duties as required or that may arise in the future.


Requirements:

  • Bachelor Degree in Biology, Chemistry, Microbiology, Engineering or Business Administration.
  • Minimum 20+ years’ experience in Pharmaceutical Industry and/or manufacturing environment or related field. Prior experience in a CDMO organization preferred.
  • Minimum 8 year’s considerable experience in supervisory/managerial roles within Quality Assurance in the Pharmaceutical Industry and experience in interaction with regulated.
  • ASQC Certification as Certified Quality Auditor (CQA) or CQE, preferred.
  • Leadership and change management skills.
  • Proficient in problem solving analysis and knowledge transfer Leadership, judgment and decision making skills. Make Rapid, Disciplined Decisions Drive Results.
  • Focus on customers and patients.
  • Communicates clearly and concisely in English / Spanish orally and written.
  • Strong critical thinking skills and Strategic Thinking.
  • Innovative mindset, Customer Oriented, Data and Fact Driven.
  • Analytical Problem Solving, implementation skills with both time and financial sensitivity.

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