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Quality specialist (Documentation)

Salary undisclosed

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Job Description Summary

Refer to JD-QA-064

QA Specialist (Compliance/ Project)

Assist the Quality Engineer to Plan, organize, coordinates and execute activities relating to quality system and

or labeling projects.

QA Specialist (Validation)

Coordinate and update the process validation activities. Responsible for process validation list update,

packaging validation work and conduct product stability testing as per B.O.P.

Job Description

Refer to JD-QA-064

QA Specialist (Compliance/ Project)

Compliance

  • Supervise daily activities of Document Controller and ensure that they adhere to instruction in the

BOPs.

  • Ensure that the Document Controllers are trained and that they adhere to instructions in the BOPs.
  • Review Division DOP to include mandatory procedures into BOPs. Write and update procedures to

incorporate mandatory requirement.

  • Responsible for the management and control of Waiver, Change Request and annual BOP review,

administration of Internal Quality Assurance Audit and coordinate corrective actions and closure for

internal & external audit performed on the facility.

Project

  • Responsible for overall coordination, supervision, and execution of project activities
  • Responsible to introduce or update all relevant documentations for project activities
  • Responsible to support and provide accurate information whenever requested by Business Unit project

personnel

Required Skills

Optional Skills

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)
Job Description Summary

Refer to JD-QA-064

QA Specialist (Compliance/ Project)

Assist the Quality Engineer to Plan, organize, coordinates and execute activities relating to quality system and

or labeling projects.

QA Specialist (Validation)

Coordinate and update the process validation activities. Responsible for process validation list update,

packaging validation work and conduct product stability testing as per B.O.P.

Job Description

Refer to JD-QA-064

QA Specialist (Compliance/ Project)

Compliance

  • Supervise daily activities of Document Controller and ensure that they adhere to instruction in the

BOPs.

  • Ensure that the Document Controllers are trained and that they adhere to instructions in the BOPs.
  • Review Division DOP to include mandatory procedures into BOPs. Write and update procedures to

incorporate mandatory requirement.

  • Responsible for the management and control of Waiver, Change Request and annual BOP review,

administration of Internal Quality Assurance Audit and coordinate corrective actions and closure for

internal & external audit performed on the facility.

Project

  • Responsible for overall coordination, supervision, and execution of project activities
  • Responsible to introduce or update all relevant documentations for project activities
  • Responsible to support and provide accurate information whenever requested by Business Unit project

personnel

Required Skills

Optional Skills

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)