[ref. p50740717] Quality specialist (Documentation) - Kulim

apartmentBecton Dickinson Global Services Centre Sdn. Bhd. placeKulim calendar_month 
Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life.

Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
Full-Time
  • Job Level:
Entry to Senior
  • Travel:
Varies
  • Salary:
Competitive
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Responsibilities

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
  1. Supervise daily activities of Document Controller and ensure that they adhere to instruction in the
BOPs.
  1. Ensure that the Document Controllers are trained and that they adhere to instructions in the BOPs.
  2. Review Division DOP to include mandatory procedures into BOPs. Write and update procedures to
incorporate mandatory requirement.
  1. 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
  1. Responsible for overall coordination, supervision, and execution of project activities
  2. Responsible to introduce or update all relevant documentations for project activities
  3. 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)
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