Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology...
harmonization process of regulatory documentation at all manufacturing sites. Requirements: MS in LifeSciences. 4-5 years...
Responsibilities and Requirements: Experience in GMP Manufacturing. Bachelor's degree in engineering. Experience writing job plans & SOPs. Experience with Optima Filling Line equipment (vial washer, Dehydrogenation tunnel, vial filling...
Responsibilities: Planning and execution of plant projects involving complex equipment changes. Work with Quality group to draft change requests and gain stakeholder alignment. Own change requests and complete change request tasks to sup...
Responsibilities: Support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate QC output;and ensure timely...
Responsibilities and Requirements: Prefer CQV experience working in a vaccine manufacturing facility The resource will need 5-10 yrs. Experience with process validation, IQ, OQ, PQ, GMP, fill finish, etc. Recipe Qualification OQ: inclu...
. Requirements: Bachelor's degree in engineering, LifeSciences, or a related field (or equivalent experience). Proven experience...
Responsibilities: Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications;Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc. Collaborate with the cross...
. Requirements: Bachelor's degree in engineering, LifeSciences, or a related field (or equivalent experience). Proven experience...
Responsibilities: Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable. Maintain knowledge of scientific literature, reg...