pharmaceutical manufacturer is recruiting for a Senior Compliance
Specialist to join their Sligo site on a 1 year fixed term contract.
As a new Snr. Compliance Specialist, you will ensure new products
transferred to the Sligo site are manufactured following applicable
regulatory requirements and policies.
_KEY RESPONSIBILITIES_
Responsible for maintaining the effectiveness of the integration of
new products into the NPI quality system.
Senior NPI Compliance Specialist is responsible for supporting new
product transfers to the site from development through to
commercialization, liaising closely with local and external
cross-functional teams to provide direction on quality concerns and
ensure appropriate mitigation to address potential risk.
Support vendor evaluation and approval, managing all technical
agreements from initiation, review, approval, and storage.
Support review and approval of NPI related Analytical Test Method
Transfers and/or validation.
Collaborate with CMC QA, R&D, S&T, and other functional groups to
maintain roles and responsibilities, identify potential quality
issues, obtain an understanding of the quality compliance and provide
input on quality concerns.
Coordination of site review of new product related material
specification documents including but not limited to intermediate
specifications, API specifications, Drug Product specifications, raw
material specifications, and excipient specifications.
Support review and approval of new product related analytical Test
Method Transfers and/or validation.
Support the management of new product related exception documentation,
including the generation of corrective and preventative action to
prevent reoccurrence.
Generation of product transfer documentation to attest the completion
of product transfer deliverables in advance of the applicable product
transfer stage gate review.
Interfaces with internal auditors and outside regulatory
agencies/auditors as the subject matter expert for new products and
technology transfers.
Adheres to and supports all EHS & E standards, procedures and
policies.
_EDUCATION_ and Technical
SKILLS:
A third level qualification in a science, quality or relevant
discipline.
A minimum of three years experience in a quality role supporting new
product introductions in Pharma or Medical Device industry.
Strong knowledge of regulatory requirements is required.
Strong interpersonal and decision-making mindset with experience
leading projects
High level of attention to detail and mental concentration to ensure
accuracy and total compliance with Quality procedures at all times.
For further information on this Senior Compliance Specialist role in
Sligo please contact Mark Wilson on +(phone number removed) or
??Check out all our open jobs on our HERO Recruitment website Senior Compliance Specialist - NPI ??My client a leading
pharmaceutical manufacturer is recruiting for a Senior Compliance
Specialist to join their Sligo site on a 1 year fixed term contract.
As a new Snr. Compliance Specialist, you will ensure new products
transferred to the Sligo site are manufactured following applicable
regulatory requirements and policies.
_KEY RESPONSIBILITIES_
Responsible for maintaining the effectiveness of the integration of
new products into the NPI quality system.
Senior NPI Compliance Specialist is responsible for supporting new
product transfers to the site from development through to
commercialization, liaising closely with local and external
cross-functional teams to provide direction on quality concerns and
ensure appropriate mitigation to address potential risk.
Support vendor evaluation and approval, managing all technical
agreements from initiation, review, approval, and storage.
Support review and approval of NPI related Analytical Test Method
Transfers and/or validation.
Collaborate with CMC QA, R&D, S&T, and other functional groups to
maintain roles and responsibilities, identify potential quality
issues, obtain an understanding of the quality compliance and provide
input on quality concerns.
Coordination of site review of new product related material
specification documents including but not limited to intermediate
specifications, API specifications, Drug Product specifications, raw
material specifications, and excipient specifications.
Support review and approval of new product related analytical Test
Method Transfers and/or validation.
Support the management of new product related exception documentation,
including the generation of corrective and preventative action to
prevent reoccurrence.
Generation of product transfer documentation to attest the completion
of product transfer deliverables in advance of the applicable product
transfer stage gate review.
Interfaces with internal auditors and outside regulatory
agencies/auditors as the subject matter expert for new products and
technology transfers.
Adheres to and supports all EHS & E standards, procedures and
policies.
_EDUCATION_ and Technical
SKILLS:
A third level qualification in a science, quality or relevant
discipline.
A minimum of three years experience in a quality role supporting new
product introductions in Pharma or Medical Device industry.
Strong knowledge of regulatory requirements is required.
Strong interpersonal and decision-making mindset with experience
leading projects
High level of attention to detail and mental concentration to ensure
accuracy and total compliance with Quality procedures at all times.
For further information on this Senior Compliance Specialist role in
Sligo please contact Mark Wilson on +(phone number removed) or
??Check out all our open jobs on our HERO Recruitment website
We need : English (Good)
Type: Permanent
Payment:
Category: Others
