Job Details: Quality Assurance Validation Specialist/Pharma / Biotech / Scientific


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Quality Assurance Validation Specialist/Pharma / Biotech / Scientific
Position: Quality Assurance Validation Specialist (Pharma / Biotech /
Scientific

We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit a Quality Assurance Validation Specialist to
join us on an initial 6 month contract. You will be responsible for
co-ordinating the validation activities within the production
facilities to ensure that the appropriate site and regulatory
standards are applied and work is completed in a timely manner.

You will perform accurate and reliable laboratory tests and generate,
report and approve results to cGMP standard, in accordance with
current company requirements and SOPs.

This role is also accountable for ensuring capital compliance with
policy and standardising and improving current processes so it is
essential you possess a high level of knowledge of Safety, Quality and
Environmental requirements.

Prior experience within a pharmaceutical / biotech environment is
essential to be considered for this position.

Further responsibilities include:

* Act as Quality Assurance approver for qualification/validation
lifecycle documents.

* Serve as a quality assurance resource for assessing validation
requirements, non-conformance, impact assessments, root cause analysis
and implementation of CAPA found during CQV activities.

* Will serve as the Quality SME for all validation activities across
the site including but not limited to Steam in Place(SIP), Cleaning
Validation & CTU (Controlled temperature Unit) Performance
qualification.

* Provide Quality Assurance Validation support for Steam In Place
(SIP) of buffer and media preparation systems, upstream (bioreactors)
and downstream equipment trains & Autoclave loads.

* Provide Quality Assurance Validation support for the Cleaning
Validation Program. Cleaning (CIP) cycles/ for buffer and media
preparation systems, upstream (bioreactors) and downstream equipment
trains, parts washers and supporting process equipment.

Qualifications & Experience

* A minimum of 3 years experience in Quality Assurance, Technical
Operations or Engineering within the Biopharma / Pharmaceutical
industry.

* Strong working knowledge of relevant cGMPs, regulations and current
industry trends.

* Experience working in regulated environment with exposure in the
Regulations & guidance&#**Apply on the website**;s - GMP, CGMP, GAMP,
**Apply on the website** CFR Part **Apply on the website**

* Technical knowledge of Cleaning validation/verification, quality
systems and regulatory requirements.

* Experience in review and approval of Cleaning Validation studies.

* Experience in review of temperature mapping studies. Ex CTU&#**Apply
on the website**;s, Autoclaves, SIP systems.

* Bachelor&#**Apply on the website**;s degree (or higher) in
Engineering, Chemistry, Biology, or relevant discipline

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible Position: Quality Assurance Validation Specialist (Pharma / Biotech /
Scientific

We are one of the largest, best known Pharmaceutical companies in the
industry and our products are known globally.

We are looking to recruit a Quality Assurance Validation Specialist to
join us on an initial 6 month contract. You will be responsible for
co-ordinating the validation activities within the production
facilities to ensure that the appropriate site and regulatory
standards are applied and work is completed in a timely manner.

You will perform accurate and reliable laboratory tests and generate,
report and approve results to cGMP standard, in accordance with
current company requirements and SOPs.

This role is also accountable for ensuring capital compliance with
policy and standardising and improving current processes so it is
essential you possess a high level of knowledge of Safety, Quality and
Environmental requirements.

Prior experience within a pharmaceutical / biotech environment is
essential to be considered for this position.

Further responsibilities include:

* Act as Quality Assurance approver for qualification/validation
lifecycle documents.

* Serve as a quality assurance resource for assessing validation
requirements, non-conformance, impact assessments, root cause analysis
and implementation of CAPA found during CQV activities.

* Will serve as the Quality SME for all validation activities across
the site including but not limited to Steam in Place(SIP), Cleaning
Validation & CTU (Controlled temperature Unit) Performance
qualification.

* Provide Quality Assurance Validation support for Steam In Place
(SIP) of buffer and media preparation systems, upstream (bioreactors)
and downstream equipment trains & Autoclave loads.

* Provide Quality Assurance Validation support for the Cleaning
Validation Program. Cleaning (CIP) cycles/ for buffer and media
preparation systems, upstream (bioreactors) and downstream equipment
trains, parts washers and supporting process equipment.

Qualifications & Experience

* A minimum of 3 years experience in Quality Assurance, Technical
Operations or Engineering within the Biopharma / Pharmaceutical
industry.

* Strong working knowledge of relevant cGMPs, regulations and current
industry trends.

* Experience working in regulated environment with exposure in the
Regulations & guidance&#**Apply on the website**;s - GMP, CGMP, GAMP,
**Apply on the website** CFR Part **Apply on the website**

* Technical knowledge of Cleaning validation/verification, quality
systems and regulatory requirements.

* Experience in review and approval of Cleaning Validation studies.

* Experience in review of temperature mapping studies. Ex CTU&#**Apply
on the website**;s, Autoclaves, SIP systems.

* Bachelor&#**Apply on the website**;s degree (or higher) in
Engineering, Chemistry, Biology, or relevant discipline

Please press apply now to submit your application. Alternatively, if
you would like further information on this position or other positions
win a similar sector, please feel free to contact our team on (phone
number removed) for a confidential conversation.

We are an equal opportunities Business. We welcome applications from
all suitably qualified candidates regardless of their race, sex,
disability, religion/belief, sexual orientation or age.

Each company within the Planet Equity Group is a "data controller".
This means that we are responsible for deciding how we hold and use
personal information about you in line with GDPR guidelines. Full
details regarding how we hold your data is available within our
Privacy Notice accessible

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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