QAQC Engineer

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific each one of our 125000 outstanding minds has a unique story to tell. Join us and give to our singular missionenabling our customers to make the world healthier cleaner and safer.

When youre part of the team at Thermo Fisher Scientific youll do important work. Surrounded by collaborative colleagues youll have the support and opportunities that only a global leader can give you. Our respected growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make meaningful contributions to the world.

The QA/QC Engineer executes planned and systematic activities implemented in a quality system so that quality requirements for products processes systems or equipment will be fulfilled. These activities include the planning and development of processes procedures and test plans in order to ensure that products manufactured meet internal customer and regulatory requirements.

Facilitate the timely and efficient receipt and dispatch of raw materials quality samples and finished goods from the site to and from service providers customers and company sites domestically and internationally.

Location: Barueri State of São Paulo

Key Responsibilities:

Quality

• Ensure all quality assurance and quality control tasks on site including documentation & training are completed in a manner aligned with GMP/ISO principles company policies and procedures.

• Coordinate with Materials Handler/Distribution personnel on export of bulk raw serum and finished good sampling for final QC testing to other Quality Control Testing/Manufacturing sites.

• Lead the receipt of additional finished goods quality samples to third-party independent quality control testing laboratories (MAPA approved)

• Complete quality documentation review and ERP release of production components raw materials and semi-finished goods at the site.

• Responsible for updating and maintaining traceability documentation (from blood collection to sterile filtration)

• Participate in the revision of quality and manufacturing documentation including batch manufacturing records (BMRs) and standard operating procedures (SOPs) and Work Instructions (WINs).

• In conjunction with the Operations Leads be accountable for aseptic cleanroom operational activities including staff training setup dispensing monitoring sampling and testing ensuring segregation of manufacturing and quality activities for both raw and finished goods.

• Ensure that environmental monitoring activities and media fill validations are performed in strict compliance to quality standards and processed independently of production activities.

• Assist with regulatory customer supplier quality audits and production activities as required.

• Manage the procurement installation set up and maintenance of critical processing equipment and plant at the site.

• Perform equipment validation calibration and maintenance activities

• Participates in Tech Transfer activities

• Works with manufacturing to investigate conduct root cause analysis recommend corrective actions for processes and products and to contribute to and track data to support at the site level (e.g. yield improvements CAPA complaint and scrap reduction)

• Influences site quality goals & objectives based on in-depth knowledge of quality standards (i.e. ISO GMP etc). Act as a subject matter expert when determining clarifications and compliance to written standards providing additional information for the site to ensure consistent application of quality processes

• Maintain and enhance the facilities and site infrastructure to be compliant to our policies ISO 9001 and cGMP requirements.

Workplace Health and Safety (WHS)

Follow all WHS procedures and policies report potential hazards and provide input into the resolution of WHS hazards / issues.

Identifying potential hazards on the site can only be done by observation of the site & the personnel working at &/or moving around the site.

Minimum Requirements/Qualifications:

• Bachelors Degree in Science or Engineering
• Minimum of 2-3 years of relevant quality experience in Medical device or Pharmaceutical industry
• Fluency in Portuguese and English
• Compliance with quality standards (e.g. EU/UK GMP 21 CFR PartISO 9001)
• Experience with MAPA GACC Market Access US Pharmacopeia European Pharmacopeia Chinese Pharmacopeia Japanese Pharmacopeia and British Pharmacopeia testing

Skills & Attributes

• Robust manufacturing process experience (i.e.: Pharma) aseptic processing
• Problem solving/excellent analytical Skills
• Financial and business aspects related to manufacturing operations
• Microsoft Office - Word Excel PowerPoint etc.
• Results driven
• Strong customer focus
• Ability to lead and motivate teams communicate effectively with diverse stakeholders (internally and externally)

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.