Job Description

Description



1. Quality Assurance Specialist

Reporting to QA Supervisor

Objective of Role

• This position is part of the Quality Assurance team responsible for implementation and maintenance of the various Quality Systems and release of incoming material to achieve the site objectives for the company.
• To build up a pipeline of skilled manpower for Singapore\'s biologics manufacturing industry Responsibilities

General responsibilities:

• Participating in investigations relating to laboratories/ incoming material release/ systems and review the

investigation report.

• Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to

ensure compliance with DM revision, where gaps are identified, ensure that an
implementation/mitigation plan is in place and follow-through to completion.

• Support the compliance, audit, regulatory and training activities as required and any other responsibilities

as assigned by Supervisor

• Leadership

o Build strong partnership with all other departments to ensure open communications and acceptance o Commitment to a fair and respectful relationship to others and behavior in accordance with the company.
Code of Conduct

• EHS

o Responsibility to adhere to any applicable EHS requirements

• Any other duties as assigned by supervisor.

Other responsibilities:

• Quality System(s) implementation and maintenance (if assigned)

o Participate in Quality System(s) rollout by ensuring that the following elements of the Quality System(s) are implemented and maintained at the site according to regulatory, corporate and division requirements:
o Nonconformance/CAPA, Change control, Incoming Release, Quality Management Review, Customer complaints, Annual Product Review/Product Quality Review, Product Recall
o Responsible for the development and writing of Quality systems and QA related procedures \xe2\x80\xa2 Perform assessments and tasks related to change controls pertaining to Quality System
o Raw Material release (if assigned)
o Responsible for the development and writing of incoming material specifications.
o Ensure timely release of incoming material
o Perform assessments and tasks related to change controls pertaining to incoming release (if assigned)

2. Quality Operations Specialist

Objective of Role

This position is a member of the Quality Operations (QO) team which is Quality representative and partner for the manufacturing and facility engineering team to ensure GMP compliance at the company

Responsibilities

• Quality Systems Representative

o Member of the QO team in ensuring Quality oversight at the manufacturing suite and/or Facility
Engineering.
o Partner the manufacturing and/or facility engineering team and helping with implementation and adherence to the various Quality systems and GMP requirements at the manufacturing suite
o Lead/organise sessions/meetings for the manufacturing and/or facility engineering team for information learning & sharing and alignment of best practices
o Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by Supervisor

• Routine QO Operations

o Revise & Participate in the development and writing of procedures pertaining to the QO
operations.
o Together with the SME, assist the manufacturing and/or facility engineering team with development and writing of process SOPs and Master Batch Records and ensure that it complies with current good practices and the applicable DMs and regulatory requirements.
o Own events relating to Quality Operations. Participating in investigations relating to manufacturing/facilities/utilities and assist in the writing and review of the investigation report relating to manufacturing/facility engineering/environmental monitoring.
o Review of the manufacturing batch records and revision of MBR/MFR/SOP.
o Participate as SME the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DMs revision, where gaps are identified, ensure that an implementation/mitigation plan is in place and follow-through to completion.
o Participate in cross-function investigations
o Support the manufacturing and/or facility engineering team with any quality interpretation,
queries and issues

• Other responsibilities (if assigned)

o Render support for timely release of bulk BDS and resolution of BDS release matters
o Provide QO related Impact Assessments for Change Controls and own Change Controls (relating to Quality Operations.
o Lead/Participate in routine GMP walk-through with manufacturing and/or facility engineering team
o Participate in all process improvements/studies with Technical Services and the manufacturing team and draft test scripts/ protocols
o Proper and timely archival of QO documents
o Manage Cell Bank and BDS Retention Samples

• Leadership

o Build strong partnership with all other departments to ensure open communications and acceptance o Commitment to a fair and respectful relationship to others and behavior in accordance with the company
Code of Conduct

• Responsibility to adhere to any applicable EHS requirements.
• Any other duties as assigned by supervisor.

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents

• Min 5 years relevant experience in a related industry preferred

• Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to (Attn: Quality Systems Specialist)

Thank You.

Recruiter\'s Ref Code: #HDC
Leon Leong De Cong

R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Oil & Gas / Petroleum / Energy
Others
Production / Manufacturing
Semiconductor / Electronics / Engineering

Specialization

Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Production / Manufacturing

Location

Central, North, East, West

Employment Type

Contract / Temp
Permanent

Salary

S$2,601 - S$4,000 / mth
S$4,001 - S$6,000 / mth

If you meet the requirements of this role, please email a detailed resume in Word document to Leon Leong De Cong.
CEI Registration No.: R1551708
Email: leonleong@recruitexpress.com.sg
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express