QC in Process Analyst

Cork  ‐ Onsite
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Description

QC in Process Analyst - GMP - Validation - CGMP - Compliance

This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

4-cycle shift (initially person may be on days for a no. of weeks to allow for training to be completed)

General Responsibilities

Achieves competency in laboratory methods and procedures.

Trains other QC analysts in laboratory methods and procedures when required.

Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.

Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.

Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.

Performs routine and non-routine analytical testing activities.

Review and approval (where appropriate) of laboratory test results.

Ensures that testing and results approval are completed within agreed turnaround times.

Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.

Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.

Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.

Deals with non-conformances/deviations in an accurate and timely manner.

Deputizes for the QC Team Leader as appropriate.

Maintains and develops knowledge of analytical technology as well as cGMP standards.

In process control testing and activities to support the production units.

Qualifications and experience

A third level qualification of a scientific/technical discipline is required.

Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

Builds strong productive relationships.

Demonstrates ability to work with teams and individuals

Asserts personal ideas and opinions using persuasion to influence others

Seeks opportunities to grow and develop professionally

Uses best practices to improve business operations

Holds self-accountable for compliant and flawless execution

Takes personal responsibility for decisions that successfully build customer value

Effectively manages and adapts to change

Demonstrates the courage to stand alone on ideas and opinions that differ from others

Listens effectively and remains open to other's ideas.

Works effectively with people that have diverse styles, talents and ideas

Maintains the highest standards of ethical behavior

Treats people with dignity and respect Significant Environmental, Health and Safety Considerations

All employees are required to comply with the requirements of the company's Environmental Health and Safety Policy, Safety Statement, associated EHS Procedures and local legislation.

Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.

Comply with EHS rules and procedures always.

Understand the potential EHS impact of their activities

Attend and participate in EHS training as required

Use PPE and safety equipment as required.

Report all incidents, accidents, and near miss events.

Report unsafe plant, equipment, acts, procedures or issues

Make suggestions to improve health and safety in the workplace.

Actively participate in work area EHS teams.

Not turn a blind eye' to unsafe acts or situations

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

Start date
ASAP
Duration
12 months
From
Elevate Direct
Published at
12.07.2018
Project ID:
1596998
Contract type
Freelance
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