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Packaging Specialist, Pharma

Job Title: Packaging Specialist, Pharma
Contract Type: Contract
Location: Dublin
Industry:
REF: 122473
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie
Job Published: about 1 year ago

Job Description

Packaging Specialist, Pharma
Our client is a major multinational pharmaceutical manufacturer based in Dublin now have a permanent role for a Packaging Specialist for their Drug Product group.


This permanent role will provide technical support on to third party manufacturers / CMOs who manufacture and pack our Drug Products, ensuring the transfer of robust packaging processes.


The successful candidate will be technical lead for creation of packaging process robustness monitoring plan, process control strategy, and provides technical oversight of TPM sites.


Key responsibilities for Packaging Specialist:
Ensure robust and compliant process performance at CMO during commercial manufacture by use of continuous process verification and OpEx.
Support CMO selection process ? compilation of technical packages, due diligence, generate scorecard ratings.
Provides technical support and leadership in serialisation activities at third parties.
Deviation Management, including leading technical investigations at third parties.
Accountable for packaging technology transfer of products, from one site to another ensuring robust technical transfer within budget constraints.
Approves site technology documents such as Technology Transfer plans, Validation Master plans, Process risk assessments etc.
Ensure compliance and security of supply ? metrics review, investigation close-out, change control review, APQR review, and process improvement. Implement / OPEX initiatives as necessary.


Key responsibilities for Packaging Specialist:
Bachelor?s Degree in Science, Engineering or similar Technical discipline.
5 years relevant experience in pharmaceutical packaging technology, technology transfer and packaging/manufacturing support/activities.
In-depth knowledge of primary and secondary packaging of pharmaceutical drug products with knowledge of global regulatory requirements related to design and control of these processes.
Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes.
Experience with the technical transfer of products to CMOs.
Ability to close-out investigations and deviations at CMOs.
Knowledge of regulations concerning cGMP, manufacturing, packaging, validation, quality systems, equipment innovations, upgrades, and instrumentation.
Excellent verbal, written communications and presentations skills, including influencing skills.


This position will require varying levels of travel- estimated at 20%.


Please phone Larry on 01-2302400 / larry@rftgroup.ie


The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie