Validation Lead QACSV

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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In Uppsala we manufacture Healon a market-leading product used to stabilize the eye in connection with eye surgery. Upon its launch in 1980 Healon paved the way for safe and quick eye surgery whereby a patients cataracts can be replaced with new lenses in just a few minutes.

J&J MedTech is recruiting for a Validation Lead QA/CSV (Quality Assurance/Computer System Validation) reporting to the Quality Director and to be based in Uppsala (Sweden).

Position summary

Responsible for leading Validation Activities within J&J Surgical Vision Uppsala and ensure validation/CSV process are in compliance with J&J internal policies and regulatory requirements.

Issue and review and approve validation/CSV documentation. Support the different functions with validation/CSV knowledge and training when necessary and Lead changes related to Validation/CSV when necessary and support as validation/CSV SME during change control process.

Responsibilities

Ensure that Validation standard procedures within AMO Uppsala AB are in compliance with

internal J&J policies and standards and external regulatory requirements.

Issue validation documentation for validation of process and product.

Ensure standards validation documentation templates according to internal J&J standard

procedures for validation of process and product.

Review and approve accounting and governing documents within validation process and

validations.

Decide on initiation of deviation and CAPA investigations according to internal procedures.

Review and approve investigations action plans and implementation of validation deviations as

Validation leader.

Participate as a validation QA representative in projects.

Act as Validation QA as described in current version of standard procedures.

Perform training related to validation process

Experience & Education

• University degree

• 3/5 years of work experience within Validation of processes equipments and/or computer system

• Experience within pharmaceutical and/or Medical Devices organizations (ISO 13485/GMP)

• Good oral and written proficiency in both Swedish and English

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