Zuellig Pharma Sdn Bhd, Assistant Quality Manager Jobs in Malaysia

 Job
Requirement

• Plans
  and schedules work for the quality department, ensuring proper
  distribution, supervision and coordination of day to day activities of
  personnel in the Quality Department.
• Plans
  and conducts meetings with subordinates to ensure compliance with
  established practices, to implement new policies, and to keep employees
  abreast of current changes and standards.
• Leads
  and develops direct reports ensuring they are competently skilled to
  perform their QA roles. Lead by example; consistently motivate staff
  through education to high levels of competency that drive success in a
  dynamic and regulated environment.
• Assists
  in the recruitment, hiring, performance reviews and enacts corrective actions,
  up to and including termination. Receives and provides feedback to staff
  on observations leading to improved adherence to GMP standards.
• Manages
  site QA operations including but not limited to calibrations management,
  validation, equipment qualification, monitoring of compliance to defined
  processes (e.g. sampling and inspection, competency checks, Key
  Performance Indicators (KPIs)), trending and analysis of KPIs, root causes
  and failure- mode impact assessments, and change management.
• nvolves
  in administrative budgets, man power budgets and training budgets for the
  Quality Assurance Department.
• Participates
  with Management to develop programs and methods to streamline center
  processes resulting in improved services and processes while maintaining compliance
  and quality.
• Reports
  concerns or deficiencies to area personnel and/or area management
  immediately. Makes recommendations for remedial actions to resolve audit
  observations and other non-compliance issues or deficiencies.
• Develops,
  reviews and maintains quality procedures and records to ensure compliance
  with quality regulations and best practices.
• Ensures
  instructions of each project in the Clinical Trial Management and its
  related procedures are adhered to and in compliance with Good Clinical Trial
  Practices.
• Reviews
  and executes validation protocols and summary reports and ensures that
  they are technically correct and in compliance with internal and external
  requirements
• Manages
  and participates in internal and external quality audits.
• Collaborates
  with cross functional personnel to provide root cause investigations and
  develops corrective actions to respond to internal and external audit
  findings.
• Brings
  together staff of different disciplines and drives the group to plan,
  formulate and agree on comprehensive quality procedures.
• Provides
  training regarding ISO9001, cGMP, GDP, GSDP and GSDPMD and standard
  operating procedures as and when necessary.
• Ensures
  there is prompt and effective communication both internally and externally
  to keep all interested parties informed proactively. This includes but not
  limited to superiors, subordinates, colleagues, clients and customers.
• Acts
  as a deputy for the Quality Manager during his absence for the smooth
  running and continuity of the department.
• Performs
  other duties as assigned when required.

• Minimum
  a Bachelor’s Degree in Science or Engineering.
• Minimum
  of 5 years’ working experience and out of which at least 2 years to be in
  a supervisory capacity for a team in the quality assurance function.
• Ability
  to work independently in a fast-paced environment.
• Ability
  to communicate at all levels within the organization as well as dealing
  with clients, customers and vendors for the effective and efficient
  meeting of goals and requirements.
• Strong
  organizational skills and attention to details to handle multiple tasks,
  short deadlines, frequent interruptions, and shifting priorities in
  support of changing company objectives
• Excellent
  critical reasoning, decision-making, and problem solving skills to analyze
  situations, determine risks, find solutions to prevent future issues and
  resolve recurring defects
• Must
  have excellent written and verbal communication skills in English.
• Those
  with good technical manufacturing knowledge – ISO 13485, cGMP, GDP, Validation,
  and Quality Management System would have an added advantage.