- Performs Q.A document control functions, documentation and record keeping processes conform to cGMP, regulatory requirement and documentation system procedure. - Assists in the day to day document and record management activities which are complying with PHARCO Pharmaceuticals procedures and regulatory requirement.
document control functions, including the issuance document processing,
document login, tracking, stamping, review, distribution and archiving of
documents to ensure documentation and record processes conform to cGMP, GDP and
version of the received procedures for review conducted prior to its issuance
to ensure the original and current version of the procedures placed in
Production Records Masters before issuance activities to make sure they comply
with the master currently version and requirements of the Good Documentations
Practices (GDP) regulation, required standards and regulations.
old (obsolete / with due date) copy, then delivers it to the archivist for
destruction issues to ensure that is no invalid document.
files the valid and obsolete documents to ensures accurate and reliable filing
systems for all paper-based GMP documents.
with QA Document Control Senior Assurer about notes and remarks to get timely
feedback on related issues.
Applies quality, environment and occupational safety and health systems to
fulfill legal requirements and other requirements of the good manufacturing
regulations of WHO guideline and international standards.
with internal regulations and the company's policies and procedures.
with Sector/Department SOPs.
and apply the requirements of ISO 9001/2015,14001/2015 and 45001/2018.
Bachelor of Science
0: 3 years
of experience in Q.A (Experience in Pharmaceutical is preferred)
skills in MS Excel, MS Power Point, MS Visio, MS Word & Oracle
Good commands in English language
Years of Experience:
1 April 2021
Application End Date:
30 April 2021
QA - Documentation