QA Operation

2 days ago

Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Main Responsibilities**:
Responsible for overseeing manufacturing, testing and validation activities, ensuring compliance with internal procedures and regulatory requirements.

**Responsibilities**:

- Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
- Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
- Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained
- Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation.
- Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits.
- Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
- Carry out additional tasks as assigned by leadership.

**About You**:

- Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- At least 3-5 years of relevant QA experience in Biopharma or Pharmaceuticals
- Familiar with FDA, EMEA, and PICS GMP requirements.
- Knowledgeable in biological product manufacturing and related quality control requirements.
- Experience in biopharma commercial supply is preferred.
- Experience with a new site start-up is preferred.
- Proficient in English listening, speaking, reading, and writing.
- Skilled in Microsoft Word, Excel, PowerPoint, etc.
- Strong learning ability.
- Excellent cross-functional communication and collaboration skills.
- Strong logical thinking and conflict management abilities.
- Demonstrates strong ownership.

**Job Type**: Contract
Contract length: 12 months

Pay: $4,500.00 - $6,000.00 per month

**Experience**:

- QA/QC: 2 years (preferred)
- Validation activities: 2 years (preferred)
- Investigation: 2 years (preferred)

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