QA Manager (Pharmaceutical)

QA Manager (Pharmaceutical)

Department: IT
Project Location(s): Chennai
Education: Any Graduate

Responsibilities

  • Plans, directs and manages the work of assigned Quality; provides technical leadership to corrective and preventive action (CAPA), deviation and change controls as necessary to ensure each project within the group is completed in accordance with departmental mission. Establishes department mission
  • Support validated systems of rfxcel by ensuring all validation activities are completed, maintained and regularly reviewed to ensure compliance to intended use
  • Participation in External Audit, Support Director with site customer audits
  • Provides oversight for the development of projects related to quality systems and continuous improvements programs.
  • Proposes and executes process and procedural changes to improve process performance, robustness, productivity and efficiency. Applies metrics to departmental mission to drive continuous
  • Collaborates functionally and cross-functionally to implement Quality strategy and objectives. Performs both independently and in team settings. Works closely with department Director to set and implement
  • Drive risk management activities, with the support of the director, within the SDLC and Change Control processes
  • Serves as Leader for new initiatives relating to department. Removes barriers to successful implementation and works to resolve
  • Ensures that all team members are compliant to all training materials and ensures timely completion of all trainings.
  • Provide on-site training to teams to ensure comprehension of procedural updates and documentation of training records

Skills/Experience

  • Skill Set: Gamp 5, ISO Audits
  • Domain: Pharmaceutical
  • Experience: 8-9 Years
  • Requires a minimum of a Bachelor’s degree in a science related discipline; Advanced degree
  • Requires a minimum of eight (8) years’ experience within a Quality unit with demonstrated abilityto execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the
  • Minimum Four (4) project management experience in a regulate industry such as healthcare
  • Strong understanding and appreciation for regulatory requirements and quality and compliance standards such as GAMP-5, ISO9001, 21CFR Part 11 and EU Annex 11
  • Expertise is performing computer systems validations and collaborating with multiple departments to deliver all validation artifacts
  • Requires strong collaboration, negotiation and ability to in a team environment and collaborate with
  • Overall understanding of Quality Systems and processes within a pharmaceutical /biopharmaceutical manufacturing organization
  • Must have demonstrated abilities in goal setting, team leadership, staff coaching and development and communication
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They reserved a good amount of time to understand my software development requirements. That translated to a high-quality product.

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