QA Ops Specialist

6 days ago

Singapore NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD. Full time
Roles & Responsibilities

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.


Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.


Successful candidates must be able to commence the program by March 2025.


Job Purpose

Responsible for providing quality oversight to ensure smooth manufacturing operation and new product launches/transfer in a compliant and timely manner. Support drug substance batch review and release in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.


Key Responsibilities

Operational

a. Provide Quality oversight to site operations/objectives

· Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.

· Participate/Support meetings (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.

b. Review/ Release of Raw materials and manufactured materials

· Perform and be responsible in ensuring Batch record review and/or release (raw materials and manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards

· Support the release team in batch release in ensuring batch release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards.

c. Support exception investigations and change control activities

· Lead/support in ensuring a smooth manufacturing operations in production/QC/Logistics, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards

d. Support OpEx improvement projects

· Support for end-to-end lifecycle management, timely review & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility

e. New Product Introduction

· Support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, , Process Validation, Ongoing Process Verification & etc

f. Customer Management

· Lead/support network/project governance meeting and team tiered process to monitor/detect/act on anomalies to project milestones, KPIs and continuous improvement.

· Support in preparing customers request documentation or requests

g. Documents review

· Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

h. Inspections

· Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits.

i. Any other task/duties assigned by Line Manager


Requirements


· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

· Several years of experience in pharmaceutical quality control, quality assurance or production or relevant quality experience. Fresh graduates are welcome to apply.

· Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

· New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation



Tell employers what skills you have

Biochemistry
Quality Control
Talent Development
Quality Assurance
GMP
Operations Management
Process Validation
Cleaning Validation
Chemistry
Manufacturing Operations
Biology
Equipment Qualification
Customer Management
Change Control

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