13 days old

QA Chemist, 23 month FTC

Pfizer
Cork
Closing date for applications is 19 October 2020.



Reporting to the QA Team Leader , a fixed term contract position has arisen within the Quality Assurance Department. The QA Chemist will be committed to continuous improvement, leading initiatives and working with site colleagues to assure high quality standards a that support the Ringaskiddy site strategy.



**Main areas of responsibility:**



**Compliance with ICHQ7 and Pfizer requirements**



+ Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing

+ Disposition of intermediates and API

+ Review and approval of deviations, change controls, SOPs, out of compliance , laboratory investigations and cleaning instructions

+ Lead /support process, equipment and cleaning validation

+ Ensure all quality systems are implemented/executed in compliance with ICH Q7 and PQS Lead periodic audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements

+ Assist with regulatory inspections Assist with the development and delivery of cGMP training Review and Approval of Project and Equipment Qualification Documentation

+ Revising SOPs and providing training as required.



**Quality Culture / CI**



+ Develop and promote a strong quality culture focused on RFT, CI and individual accountability

+ Lead/support root cause analysis investigations including Pfizer Human Performance (PHP) investigations and quality risk assessments to ensure effective investigations to identify and implement CAPAs within the agreed timeframe Execute/support projects to drive quality excellence (using benchmarking as required)

+ Lead/ support site projects as required

+ Work within a process centric team driven organization in order to achieve high levels of performance and continuous improvement

+ Support internal audit program and weekly walk through audits.



**Batch release (supply)**



+ Responsible for batch release lead time enabling on time production and shipping

+ Enable release adherence to the planned production and shipping schedule Deliver on target batch review times



**Safety**



+ Responsible for initiating and investigating SII and completion of safety actions



**The successful candidate should have:**



+ BSc in Chemistry or equivalent.

+ Thorough knowledge of GMP's and regulatory expectations for manufacturing of APIs

+ Relevant years of experience working in the pharmaceutical manufacturing industry, preferably in Quality or a related Technical function.

+ The ideal candidate will be a self starter with the ability to work on their own initiative and within teams.

+ Strong communication and organizational skills are important with the ability to build relationships internally and externally

+ Excellent ability to deliver results, with strong interpersonal and influencing skills.



**How to apply**



Make a difference today, all suitable candidates should apply with CV. We are looking forward to hear from you!



**Additional Information**



+ In order to be considered for this position you need to be legally eligible to work in Ireland.

+ Please note there is no relocation support available for this position

+ Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

+ Due to high volume of applications we will be contacting successful candidates only.



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Quality Assurance and Control

Categories

Posted: 2020-10-06 Expires: 2020-11-05

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QA Chemist, 23 month FTC

Pfizer
Cork

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