* The PDS (Process development services) QA Manager is responsible for
providing Quality leadership for the PDS QA operations for the site,
which are responsible for The quality oversight and execution of
compliance activities associated with new product introduction (both
clinical and commercial) and significant changes to established
products Effective governance and alignment of the Thermo Fisher
Scientific Cork change control process, to meet site needs, ensuring
local change control procedures meet the requirements of our PQS and
the relevant changes are managed accordingly Co-ordination, support,
execution and SME advise on all aspects of validation on site
The role is key in establishing robust and compliant ways of working
in a rapidly growing site delivering in a contract development and
manufacturing services industry with a complex customer base across
Clinical and Commercial manufacture.
Operating for over **Apply on the website** years, the Cork site is
proud to manufacture and supply Active Pharmaceutical Ingredients
(API) to our customers for use in clinical trials and approved
medicines for commercial supply - medicines to treat Cancer,
Parkinson?s Disease, Depression, HIV, Congestive Heart Failure,
Diabetes and Respiratory diseases, along with raw material for
consumer healthcare products. The Cork site is welcoming exciting
growth and new expansions to support much-needed capacity for APIs
currently in development and the increasing needs of customers and the
patients we serve.
* What will you do?
** Responsible for management of all Quality oversight, compliance and
execution of QA activities necessary for the introduction of new
products to the site (clinical and commercial) and significant changes
to established products including
* Client interface/engagement
* Quality Agreement review
* Execution of all activities required for manufacture of clinical and
commercial products are aligned to relevant site SOP?s
* Ensuring the appropriate validation activities are co-ordinated and
supported on site
* Ensure that the obligations of an independent Quality Unit (within
area of responsibility) according to ICH Q7: ?Good Manufacturing
Practice for Active Pharmaceutical Ingredients? are assumed
* Responsible for ensuring overall governance for Thermo Fisher
Scientific Cork Change Control process ensuring the Change control
process is effective, efficient and capable of meeting site needs as
CDMO with varying levels of change (for clinical and commercial
supply).
* Developing and maintaining positive relationships with key internal
and external customers, will personally be involved with the
management of key accounts.
* Develop a fit for purpose PM system for the PDS QA group that aligns
with the needs of a CDMO organization.
* Development and Collation of PDS QA KPI?s to adequately visualise
the group performance and drive continuous improvement.
* Ensure effective Planning in place for new product introductions
* Ensure client audits are facilitated and effectively managed
* Ensure a strong link between the PDS and MS&T functions to enable a
successful introduction and manufacturing execution of new products.
* Be flexible and able to adjust to the business needs in a fast pace
CDMO environment.
* Directing QA PDS operations in support of and in concert with
Business leaders to drive results, establish objectives and ensure
appropriate steps are taken to identify compliance gaps and put
corrective and preventative actions in place.
* Supporting implementation of current and long range objectives and
activities in accordance with policies, goals and objectives
established by the Site Quality Director and the site leadership team.
* Developing and maintaining positive relationships with key internal
and external customers, will personally be involved with the
management of key accounts; will represent the company as appropriate
in its relationships with external entities.
* Support the significant event escalation process to ensure effective
solution/resolution. This includes ensuring there is internal
communication within PDS and MS&T of all significant customer
relationship quality issues, needs, and developments.
* Support execution of a robust site quality plan; PQS implementation
and Quality succession planning.
* Emphasizing the critical need for on-time delivery through the lens
of full compliance; driving this focus across all levels of the
organization.
* Ensuring PPI (Practical Process Improvement) is embraced within the
PDS QA organization in order to identify process gaps and global
alignment needs within the organization leading to process improvement
initiatives.
* Serve as a Role Model Leader demonstrating strong communication and
interactions with colleagues at all levels, promoting positive
employee relations.
* Who we are looking for: ?
** BSc Hons Degree Science, and/or higher degree
* Detailed knowledge of the cGMP requirements relevant to the role
* 2+ years? experience in a pharma manufacturing operations in a
highly regulated environment
* Understanding and ability to adhere to established quality standards
and regulatory compliance requirements preferred.
* Collaboration skills
? _ABLE TO_ effectively collaborate with peers in other functions
and with colleagues in other businesses or divisions
* Ability to lead, motivate and influence others within a team. Highly
talented at team building, coaching and mentoring with a passion for
inspiring others.
* Ability to manage multiple priorities and projects in a
cross-functional environment.
* Ability to apply data analytics and risk-based decision making.
* Embodies our Thermo Fisher values of Integrity, Involvement,
Intensity and Innovation.
* What?s in it for you:
** Competitive base salary
* Annual bonus
* Contributory Pension
* Private medical insurance
* Free onsite parking
* About us:
* Thermo Fisher Scientific Inc. is the world leader in serving
science, with annual revenue exceeding $**Apply on the website**
billion. Our Mission is to enable our customers to make the world
healthier, cleaner and safer. Whether our customers are accelerating
life sciences research, solving complex analytical challenges,
improving patient diagnostics and therapies or increasing productivity
in their laboratories, we are here to support them.
Our global team of more than **Apply on the website**,**Apply on the
website** colleagues delivers an unrivaled combination of innovative
technologies, purchasing convenience and pharmaceutical services
through our industry-leading brands, including Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services
and Patheon
With Thermo Fisher Scientific, it?s not just a career. ?It?s a
chance to realise your best ? professionally and personally.
Apply today! (Use the "Apply for this Job" box below). * The job:
* The PDS (Process development services) QA Manager is responsible for
providing Quality leadership for the PDS QA operations for the site,
which are responsible for The quality oversight and execution of
compliance activities associated with new product introduction (both
clinical and commercial) and significant changes to established
products Effective governance and alignment of the Thermo Fisher
Scientific Cork change control process, to meet site needs, ensuring
local change control procedures meet the requirements of our PQS and
the relevant changes are managed accordingly Co-ordination, support,
execution and SME advise on all aspects of validation on site
The role is key in establishing robust and compliant ways of working
in a rapidly growing site delivering in a contract development and
manufacturing services industry with a complex customer base across
Clinical and Commercial manufacture.
Operating for over **Apply on the website** years, the Cork site is
proud to manufacture and supply Active Pharmaceutical Ingredients
(API) to our customers for use in clinical trials and approved
medicines for commercial supply - medicines to treat Cancer,
Parkinson?s Disease, Depression, HIV, Congestive Heart Failure,
Diabetes and Respiratory diseases, along with raw material for
consumer healthcare products. The Cork site is welcoming exciting
growth and new expansions to support much-needed capacity for APIs
currently in development and the increasing needs of customers and the
patients we serve.
* What will you do?
** Responsible for management of all Quality oversight, compliance and
execution of QA activities necessary for the introduction of new
products to the site (clinical and commercial) and significant changes
to established products including
* Client interface/engagement
* Quality Agreement review
* Execution of all activities required for manufacture of clinical and
commercial products are aligned to relevant site SOP?s
* Ensuring the appropriate validation activities are co-ordinated and
supported on site
* Ensure that the obligations of an independent Quality Unit (within
area of responsibility) according to ICH Q7: ?Good Manufacturing
Practice for Active Pharmaceutical Ingredients? are assumed
* Responsible for ensuring overall governance for Thermo Fisher
Scientific Cork Change Control process ensuring the Change control
process is effective, efficient and capable of meeting site needs as
CDMO with varying levels of change (for clinical and commercial
supply).
* Developing and maintaining positive relationships with key internal
and external customers, will personally be involved with the
management of key accounts.
* Develop a fit for purpose PM system for the PDS QA group that aligns
with the needs of a CDMO organization.
* Development and Collation of PDS QA KPI?s to adequately visualise
the group performance and drive continuous improvement.
* Ensure effective Planning in place for new product introductions
* Ensure client audits are facilitated and effectively managed
* Ensure a strong link between the PDS and MS&T functions to enable a
successful introduction and manufacturing execution of new products.
* Be flexible and able to adjust to the business needs in a fast pace
CDMO environment.
* Directing QA PDS operations in support of and in concert with
Business leaders to drive results, establish objectives and ensure
appropriate steps are taken to identify compliance gaps and put
corrective and preventative actions in place.
* Supporting implementation of current and long range objectives and
activities in accordance with policies, goals and objectives
established by the Site Quality Director and the site leadership team.
* Developing and maintaining positive relationships with key internal
and external customers, will personally be involved with the
management of key accounts; will represent the company as appropriate
in its relationships with external entities.
* Support the significant event escalation process to ensure effective
solution/resolution. This includes ensuring there is internal
communication within PDS and MS&T of all significant customer
relationship quality issues, needs, and developments.
* Support execution of a robust site quality plan; PQS implementation
and Quality succession planning.
* Emphasizing the critical need for on-time delivery through the lens
of full compliance; driving this focus across all levels of the
organization.
* Ensuring PPI (Practical Process Improvement) is embraced within the
PDS QA organization in order to identify process gaps and global
alignment needs within the organization leading to process improvement
initiatives.
* Serve as a Role Model Leader demonstrating strong communication and
interactions with colleagues at all levels, promoting positive
employee relations.
* Who we are looking for: ?
** BSc Hons Degree Science, and/or higher degree
* Detailed knowledge of the cGMP requirements relevant to the role
* 2+ years? experience in a pharma manufacturing operations in a
highly regulated environment
* Understanding and ability to adhere to established quality standards
and regulatory compliance requirements preferred.
* Collaboration skills
? _ABLE TO_ effectively collaborate with peers in other functions
and with colleagues in other businesses or divisions
* Ability to lead, motivate and influence others within a team. Highly
talented at team building, coaching and mentoring with a passion for
inspiring others.
* Ability to manage multiple priorities and projects in a
cross-functional environment.
* Ability to apply data analytics and risk-based decision making.
* Embodies our Thermo Fisher values of Integrity, Involvement,
Intensity and Innovation.
* What?s in it for you:
** Competitive base salary
* Annual bonus
* Contributory Pension
* Private medical insurance
* Free onsite parking
* About us:
* Thermo Fisher Scientific Inc. is the world leader in serving
science, with annual revenue exceeding $**Apply on the website**
billion. Our Mission is to enable our customers to make the world
healthier, cleaner and safer. Whether our customers are accelerating
life sciences research, solving complex analytical challenges,
improving patient diagnostics and therapies or increasing productivity
in their laboratories, we are here to support them.
Our global team of more than **Apply on the website**,**Apply on the
website** colleagues delivers an unrivaled combination of innovative
technologies, purchasing convenience and pharmaceutical services
through our industry-leading brands, including Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services
and Patheon
With Thermo Fisher Scientific, it?s not just a career. ?It?s a
chance to realise your best ? professionally and personally.
Apply today! (Use the "Apply for this Job" box below).
We need : English (Good)
Type: Permanent
Payment:
Category: Others
