Quality Assurance Lead : Quality Engineering

Quality Assurance Lead : Quality Engineering
Company:

(Confidential)


Quality Assurance Lead : Quality Engineering

Details of the offer

The Quality Assurance Lead supports the day:to:day quality operations of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, and data integrity with a focus on quality engineering and validation aspects of biologics manufacturing production.

Key result areas (major duties, accountabilities and responsibilities)

Perform reviews of Validation Lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reports from a quality perspective to ensure compliance to internal requirements.
Perform reviews of protocols and reports relating to Facilities, Utilities, and Equipment commissioning and qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance to internal requirements and sound technical rational.
Review and approve deviations and CAPAs; including performing Failure Mode Effect Analyses (risk assessments), participating in root cause analysis investigations and evaluating CAPA effectiveness.
Review and approve change controls with a focus on those pertaining to equipment, facilities, utilities and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
Review and approve preventative maintenance, calibration, and work order documentation.
Support internal audits.
Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
Represent Quality Assurance on project teams and in meetings.
Support the continuous improvement and oversight of Quality Management System procedures.
Provide any additional QA support as necessary (eg Review and approve batch records, lot release).

Qualifications

A minimum of a Bachelors degree in Life Sciences or Engineering
8:10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Preferred experience in validation.
Well versed in cGMP/ICH/FDA/EU regulations and guidelines
Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)

Core competencies

Strong communication skills
Strong organizational skill
Capable of working with minimal supervision
Ability to work well with diverse groups
Ability to manage multiple activities with challenging timelines


Source: Tiptopjob_Xml


Area:

Requirements


Knowledges:

  • Utilities

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