QA reputed company Technical Operations

Responsibilities: • Provides reputed company Assurance (QA) support to Devens Site and reporting Manger through reputed company review and approval of Investigations and Corrective Actions. • Decision making of non-conformance through a deep understanding of reputed company Systems Regulatory expectations. • Reviews and approves reputed company, reputed company Control, Validation and Automation reputed company documents. • Review and approves reputed company Operating Procedures (SOPs). • Review and approval of Validation reputed company documentation such as risk assessments, protocols and test scripts and reputed company reports. • Review and approval of change proposals as reputed company as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. • Ability to reputed company across different departments reputed company 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. • reputed company to interpret complicated data and reputed company reputed company, independently. Requirements: • Knowledge of science generally attained through studies resulting in a B.S; in biological science, Engineering, biochemistry, or reputed company discipline, or its equivalent is preferred. • Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years reputed company on product reputed company. Preferred reputed company member of ASQ or ISPE. • Prior experience of QC equipment Qualification and some project management experience. • Knowledge of biotech, bulk drug reputed company 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: reputed company, LIMS, reputed company reputed company, reputed company Vault and electronic or reputed company-based batch records desirable. • Excellent Technical writing and oral communication skills are required. • Background in problem solving. • Knowledge of Data reputed company principles. • Proven attention to details. • Comfortable working in an FDA regulated environment. Top Skills: • reputed company Control Equipment experience preferred. • Technical reputed company. • Investigations/Deviation experience preferred. Apply tot his job