QC Lead SUMMARY OF POSITION:
The Quality Control (QC) Lead will manage the operation of the QC
function within the College Park manufacturing site. The role will
ensure adherence with regulatory and best practice requirements while
delivering consistently for the internal and external customer.
ESSENTIAL FUNCTIONS:
Principal business owner for College Park QC Budget responsibility to
ensure costs are managed appropriately Responsible for establishing &
maintaining the QC laboratory and QC QMS Manage, motivate and develop
the QC team Build and maintain strong cross functional relationships
across the site Responsible for analytical method transfer, test
scheduling, ongoing testing and coordination of the stability
programme Review & approval of all analytical methods, validation
protocols, reports, and method transfer protocols Review release and
stability specifications for raw materials, drug substance and drug
product& propose and revise specifications as necessary.
Review and approve analytical data to raw materials, support drug
substance and drug product manufacturing testing, stability and
release. To ensure customer satisfaction through continuous
improvement & RFT Prepare, review and approve documentation. SOP?s,
trending, metrics, training etc. Ensure laboratories, systems and
equipment are GMP compliant and audit ready Ensure that QC change
controls, any formal investigations e.g. Out of
-Specification (**Apply on the website**S), Deviations in Data, are
conducted promptly and thoroughly. Keep up to date with technical
advances in analytical and pharmaceutical sciences. Promote & deliver
continuous improvement within the QC Ensure that analyses of
experimental and stability samples are coordinated and conducted
strictly in accordance with cGMPs, applicable Pharmacopeia,
company&#**Apply on the website**;s SOPs, methods and protocols Lead
and/or partner for the Annual Product Review process and lead in
regulatory audits on QC aspects.
To ensure Key Performance Indicator?s are known, promoted and
achieved Ensure compliance with all EHS site procedures Qualifications
and Knowledge
REQUIREMENTS:
Minimum Degree qualification in a related discipline (Chemistry,
Biotechnology etc.) 8 or more years relevant experience in a cGMP
commercial manufacturing environment Chemical & Biological background
with experience of working in / leading a QC team The individual needs
to be self-motivated and self-managing
_ABLE TO_ identify, execute and prioritize work/projects and escalate
when required Experience in working in start-up desirable
Competencies/Preferred
SKILLS:
Self-starter with strong work ethic Excellent written and verbal
communication skills,
_MUST BE_ able to perform at a high level with limited supervision
_ABILITY TO_ use leadership skills to positively manage issues. Strong
influencing skills Self-motivated and self-managing.
_ABLE TO_ identify, execute and prioritize work tasks/projects with an
awareness of escalation responsibility as needed. Critical
problem-solving skills Demonstrated data driven decision making
ability Good computer skills, including proficiency with business and
technical software (Word, Excel, PowerPoint, Project, Empower, Tiamo,
SAP, LIMS,)
_ABILITY TO_ plan, organize, and prioritize projects to schedule
Excellent technical and compliance-based writing skills
_ABILITY TO_ manage projects involving multiple functional groups
without direct reporting authority Other Skills/
COMPETENCIES:
Demonstrated leadership abilities Demonstrated commitment to excellent
customer service Conflict resolution skills Requires mature judgment
in problem solving situations. Requires negotiation skills to
effectively influence others
_ABILITY TO_ identify and drive continuous quality improvement - Six
Sigma Black Belt or Lean Certification an advantage #LI-CL1 JOB DESCRIPTION
QC Lead SUMMARY OF POSITION:
The Quality Control (QC) Lead will manage the operation of the QC
function within the College Park manufacturing site. The role will
ensure adherence with regulatory and best practice requirements while
delivering consistently for the internal and external customer.
ESSENTIAL FUNCTIONS:
Principal business owner for College Park QC Budget responsibility to
ensure costs are managed appropriately Responsible for establishing &
maintaining the QC laboratory and QC QMS Manage, motivate and develop
the QC team Build and maintain strong cross functional relationships
across the site Responsible for analytical method transfer, test
scheduling, ongoing testing and coordination of the stability
programme Review & approval of all analytical methods, validation
protocols, reports, and method transfer protocols Review release and
stability specifications for raw materials, drug substance and drug
product& propose and revise specifications as necessary.
Review and approve analytical data to raw materials, support drug
substance and drug product manufacturing testing, stability and
release. To ensure customer satisfaction through continuous
improvement & RFT Prepare, review and approve documentation. SOP?s,
trending, metrics, training etc. Ensure laboratories, systems and
equipment are GMP compliant and audit ready Ensure that QC change
controls, any formal investigations e.g. Out of
-Specification (**Apply on the website**S), Deviations in Data, are
conducted promptly and thoroughly. Keep up to date with technical
advances in analytical and pharmaceutical sciences. Promote & deliver
continuous improvement within the QC Ensure that analyses of
experimental and stability samples are coordinated and conducted
strictly in accordance with cGMPs, applicable Pharmacopeia,
company&#**Apply on the website**;s SOPs, methods and protocols Lead
and/or partner for the Annual Product Review process and lead in
regulatory audits on QC aspects.
To ensure Key Performance Indicator?s are known, promoted and
achieved Ensure compliance with all EHS site procedures Qualifications
and Knowledge
REQUIREMENTS:
Minimum Degree qualification in a related discipline (Chemistry,
Biotechnology etc.) 8 or more years relevant experience in a cGMP
commercial manufacturing environment Chemical & Biological background
with experience of working in / leading a QC team The individual needs
to be self-motivated and self-managing
_ABLE TO_ identify, execute and prioritize work/projects and escalate
when required Experience in working in start-up desirable
Competencies/Preferred
SKILLS:
Self-starter with strong work ethic Excellent written and verbal
communication skills,
_MUST BE_ able to perform at a high level with limited supervision
_ABILITY TO_ use leadership skills to positively manage issues. Strong
influencing skills Self-motivated and self-managing.
_ABLE TO_ identify, execute and prioritize work tasks/projects with an
awareness of escalation responsibility as needed. Critical
problem-solving skills Demonstrated data driven decision making
ability Good computer skills, including proficiency with business and
technical software (Word, Excel, PowerPoint, Project, Empower, Tiamo,
SAP, LIMS,)
_ABILITY TO_ plan, organize, and prioritize projects to schedule
Excellent technical and compliance-based writing skills
_ABILITY TO_ manage projects involving multiple functional groups
without direct reporting authority Other Skills/
COMPETENCIES:
Demonstrated leadership abilities Demonstrated commitment to excellent
customer service Conflict resolution skills Requires mature judgment
in problem solving situations. Requires negotiation skills to
effectively influence others
_ABILITY TO_ identify and drive continuous quality improvement - Six
Sigma Black Belt or Lean Certification an advantage #LI-CL1
We need : English (Good)
Type: Permanent
Payment:
Category: Others
