Quality Compliance

2 weeks ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

Contract basic for 6 months, 5 days (8a-5pm). Hybrid work model: Home/Tuas site (Company bus available at multiple locations)

**Profile Details**

**Purpose**
- Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).
- Supports the preparation and management of external and corporate audits and Health Authority inspections.

**Major Accountabilities**
- Planning and supporting PQR/APQR activities
- Support site qualification and validation activities (planning, advising, review)
- Implementation of Quality Systems (incl. documentation management)
- Supplier management activities (agreements, oversight, audit)
- Preparation/support and coordination of CAPA/follow-up
- Audit and inspection preparation and support
- Change control review/approval
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance acc. to regulations
- QP declaration review and approval
- KPI trending
- SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for

all sites within same HA jurisdiction / country

**Additional Specifications**

In addition to the defined accountabilities of Job Profile the following accountably are relevant:

- Audit and inspection preparation and support
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk identification etc) - As required
- Exception investigation support - As required
- Review and approval of production, QC and AS&T records incl. MBR - As required
- Executes batch release in compliance with registration - As required
- QA oversight of production and testing activities (shop-floor presence), ensuring compliance with cGxP, incl. DI and eCompliance, eg. PU GMP SPOC - As required

**Key Performance Indicators (KPIs)**
- Ensures planning and successfully supports PQR/APQR activities
- successfully carries out site qualification and validation activities (planning, advising,

review)
- supports the implementation of Quality Systems (incl. documentation management); Ensure

local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance according to regulations

**Ideal Background**

**Education & Qualifications**
- BSc in Life Sciences, Biotech, or related experience (pharmaceutical manufacturing)

**Languages**
- English - fluent in speaking and writing

**Experiences**
- Professional experience (ca. 3-5 years) in GMP environment and analytics (e.g., Quality Control)
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones
- Fresh graduate with relevant experiences may be considered



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