Engineering Jobs at Aspen – Validation Officer

Aspen is looking for a Validation Officer to be based on one of their Port Elizabeth operations. Job seekers who have relevant qualification are encouraged to apply for the position. If you are interested in the Validation officer job apply before the closing date: 30/06/2022. For more job opportunities and others In South Africa – browse now at Mzansi-Vacancies.co.za

About Aspen

Aspen is a global specialty and branded pharmaceutical firm committed to enhancing patients’ health throughout the globe with high-quality, affordable medications. They are involved at every point in the value chain and have outstanding diversity in terms of their operations, products, and production capacity.

Aspen is a dynamic company with a strong sense of foresight and entrepreneurship. They are looking for high-achievers that are passionate about their profession and push themselves to go above and beyond. In addition to hiring the best candidates, Aspen offers a wide range of growth opportunities.

They are capable of producing steriles, liquids, semi-solids, biologicals, active pharmaceutical components, and oral solid dosage, among other things. We hold global production permits from some of the strictest international regulatory agencies, including the European Directorate for the Quality of Medicines, the Australian Therapeutic Goods Administration, and the US Food and Drug Administration, among others.

Their high-quality, affordable medications benefit patients in more than 150 countries, and they employ around 9100 people across 69 facilities in more than 50 countries.

Working at Aspen

Aspen is an organization with a strong focus on innovation and entrepreneurship. They draw high-achievers who are driven to exceed expectations and are passionate about their work. Aspen doesn’t just look for the top people; they also provide a variety of possibilities for ongoing growth.

Job Details

Minimum Experience	Skilled
Company main industry	Pharmaceutical
Functional Area	Validation Officer
Contract term	Permanent
Salary	Market related
Ref	AP-3326

Location: Port Elizabeth, South Africa

Date of Closing: Not Specified

Engineering Jobs at Aspen – Validation Officer

Description

Overview

Perform validation exercises of production and lab equipment, utilities, packaging and processes to ensure specific standard of compliance is met

Responsibilities

Planning and Operational Support

Act as a technical/ subject matter resource
Facilitate implementation of current processes
Identify gaps in current policies and procedures
Provide input into changes or improvements to processes, tools and techniques

Validation

Perform validation exercises in compliance with GMP standards and validation schedules
Maintain compliant status of equipment and processes (systems, cleaning

Qualification

Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use
Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits
Investigate and report OOE results, and perform re-tests
Participate in change control assessments to ensure compliant status of affected equipment is not compromised
Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
Ensure documents and procedures to operate and maintain equipment are in place

Requalification

Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol
Prepare and perform re-qualification of equipment and utilities as per SOP

Reporting and Record-Keeping

Compile, maintain and update validation documentation as per SOP and QMS
Generate validation reports on a weekly/ monthly basis

Requirements

Background/experience

National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products
Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes and objectives