Job description

Hi,

Greeting from infinity quest,

We have a opening for Below requirement

* Only citizen And locals

Job Title: QA Validation Engineer

Location: 38 Jackson Rd, Devens, MA 01434 (Onsite)

Duration: 12+ Months

Visa Status: US Citizen/Green Card

Work Schedule- Monday through Friday - 1st shift

Minimum 50% onsite and some activities can be done remote and other activities must be done onsite contractor must be able to come onsite when needed(First preference local candidates)

MUST BE FULLY VACCINATED

Interview Process: Virtual

Usually starts with a phone interview and then a video call (Panel Interview).

Note:

• Would like 12 years exp BUT 10 years is okay
• Pharma background is must
• Strong validation / Quality Control
• Automation - not related to IT
• More Pharma rather than CORE Automation
• Validation / Copa / Risk Assessment / Investigation

Manager is looking for strong experience in Validation, Quality control, GMP and pharma/manufacturing background with 10+ years of experience

• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.

• Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions.

• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations

• Reviews and approves Quality, Quality Control, Validation and Automation related documents

• Review and approve Standard Operating Procedures (SOPs).

• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.

• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.

• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.

• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment

• Able to interpret complicated data and make sound decisions, Independently

This position will regularly interact with:

Reporting Senior Manager

Sometimes will interact with departments listed below:

Quality Control

Manufacturing Operations

Manufacturing Engineering

Manufacturing Science and Technology (MS&T)

Validation

Site Engineering

Digital Plant

Qualifications:

Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.

• Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.

• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.

• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.

• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.

• Excellent Technical writing and oral communication skills are required.

• Background in problem solving

• Knowledge of Data integrity principles

• Proven attention to details

• Comfortable working in an FDA regulated environment.

Thanks,

Lakshmi

Infinity Quest

LAKSHMI.R@i-q.co

732-234-414

Job Type: Contract

Salary: $60.00 - $75.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Speak with the employer
+91 8946005419

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