Clinical / Scientific - Safety and Regulatory Quality Control - Pioneer Data Systems
Groton, CT 06340-5146
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in Groton, CT is currently looking for an QA Validation Engineer to join their expanding team.
Job Title: QA Validation Engineer / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 months
Location: Groton, CT
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
As a Quality Assurance Manager Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pharmaceutical Groton, CT site.
This is an onsite role with a Monday -Friday , 1st Shift schedule.
Role Responsibilities:
Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews.
Quality lead on large projects and contributes to validation strategy.
Participate and/or lead quality investigations including root cause analysis, Pharmaceutical Human Performance assessments, and approval of investigation reports.
Review and approve change controls, quality investigations, and corrective/preventive actions.
Participate in the development of procedures which increase efficiency while maintaining high quality standards
Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.
Participate on special projects, teams and global initiatives.
Basic Qualifications
Bachelor's Degree (B.S.) with 3-5 years technical/scientific/pharmaceutical experience/Engineering or equivalent.
Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
Preferred Qualifications
Extensive knowledge of cGMP's related to equipment and computer system validation/qualification.
Expertise in quality investigation techniques
Experience with Quality Risk Management (QRM)
Previous quality assurance experience
Minimum Education:
Bachelor's Degree (B.S.) with 3-5 years technical/scientific/pharmaceutical experience/Engineering or equivalent.
Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
Our client, a world-leading Pharmaceutical Company in Groton, CT is currently looking for an QA Validation Engineer to join their expanding team.
Job Title: QA Validation Engineer / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 months
Location: Groton, CT
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
As a Quality Assurance Manager Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pharmaceutical Groton, CT site.
This is an onsite role with a Monday -Friday , 1st Shift schedule.
Role Responsibilities:
Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews.
Quality lead on large projects and contributes to validation strategy.
Participate and/or lead quality investigations including root cause analysis, Pharmaceutical Human Performance assessments, and approval of investigation reports.
Review and approve change controls, quality investigations, and corrective/preventive actions.
Participate in the development of procedures which increase efficiency while maintaining high quality standards
Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.
Participate on special projects, teams and global initiatives.
Basic Qualifications
Bachelor's Degree (B.S.) with 3-5 years technical/scientific/pharmaceutical experience/Engineering or equivalent.
Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
Preferred Qualifications
Extensive knowledge of cGMP's related to equipment and computer system validation/qualification.
Expertise in quality investigation techniques
Experience with Quality Risk Management (QRM)
Previous quality assurance experience
Minimum Education:
Bachelor's Degree (B.S.) with 3-5 years technical/scientific/pharmaceutical experience/Engineering or equivalent.
Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
Source : Pioneer Data Systems
