Specialist - QA Ops - Manufacturing Mgmt

Specialist - QA Ops - Manufacturing Mgmt

Job ID: REQ-10007341

Date: May 21, 2024

Summary

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

About the Role

Position Title: Specialist - QA Ops - Manufacturing Mgmt

Key Responsibilities:

1. Ensure all activities are in compliance with cGxP, including data integrity.
2. Review and approval of analytical data/tests (analytical release).
3. Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
4. Support exception investigations.
5. Review and approval of production, QC, and AS & T records.
6. MBR review. Support OpEx improvement projects. Execute batch release in compliance with registration (if Qualified Person).
7. Comply with all HSE guidelines. Detect and report potential accidents, risks, and propose solutions.
8. Participate in HSE risk assessments. Preparation and participation in internal HSE audits.

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

Essential Requirements:

1. 3+ years of experience in pharmaceutical quality control, quality assurance, or production.
2. Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice.
3. Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy.
4. MS Office applications and other standard IT applications supporting Quality activities.
5. Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing.

Desirable Requirements:

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

Why Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Benefits

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Join Our Novartis Network

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis 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

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