Senior Specialist, QA Operations Life Cycle Management

Senior Specialist, QA Operations Life Cycle Management

Job ID: REQ-10018413

Date: Aug 12, 2024

Summary

Responsible for managing quality aspects within the area of responsibility and ensuring that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements, and the Novartis Quality Manual, conducted according to the relevant Standard Operating Procedures.

About the Role

Position Title: Senior Specialist, QA Ops - Lifecycle Management

This role supports/provides quality oversight in ensuring a smooth manufacturing operation, new product launches/transfers in a compliant/timely manner, drug substance batch review/release are in full GMP compliance with regulatory standards, and ensures quality strategy/continuous improvement are executed in alignment with site objectives.

Key Responsibilities

Your responsibilities include, but are not limited to:

1. Operational:
   • Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
   • Support exception investigations (complex/critical).
   • Support change control activities relating to complex changes.
   • Support OpEx improvement projects.
   • Execute batch release in compliance with registration according to local requirements as the technical responsible person.
2. HSE:
   • Comply with all HSE guidelines.
   • Detect and report potential accidents, risks, and propose solutions.
   • Participate in HSE risk assessments.
   • Preparation and participation in internal HSE audits.
   • Responsible for participating in initial training and retraining.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

• University degree with a scientific/technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).
• 8-10 years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits, or new product launches/tech transfer.
• Several years of experience in pharmaceutical quality control, quality assurance, or production.
• GMP experience will be an added advantage.
• Strong organizational and time management skills.
• Quality-oriented with attention to detail.
• Highly proactive, self-motivated, professional, and dedicated.

Why consider Novartis?

236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives, and ground-breaking solutions can be found at the intersection of medical science and digital innovation. A diverse, equitable, and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network

If this role is not suitable for your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.