* Join a company that has developed a stand-out culture of
innovation, inclusion and development, and consistently features as a
great place to work.
* Generous package with good base salary and benefits to including
but not limited to health insurance, pension and bonus.
* Join an organization who embrace diversity, equality and inclusion
and puts patients first.
* Work with innovative new technologies, in combination with the
depth of expertise that exists within the local workforce, that have
allowed our client to develop and deliver products and processes to
support their wider global needs. These range from small scale
clinical trial supply to large commercial manufacturing.
WHAT YOU WILL BE DOING:
* Allocate the work of the department to the QC staff to ensure
effective schedule adherence
* Supervise the work performed in the QC department and perform
annual appraisals of QC staff while insuring up to date training and
development
* Control products (raw materials, intermediates, and finished
products) by following procedures (general, specific, of analysis and
use, and qualification of equipment) so as to meet schedule demands
* Review analytical data and approve and release material as defined
in relevant procedures
* Coordinate and manage equipment maintenance and repair activities
* Deliver operating budgets, ordering, and supervise expenditure
* Maintain an awareness of technical developments for
instrumentation analysis and schedule training for the team as
appropriate
* Perform investigations, and ensure a follow-up on anomalies,
failures, and external complaints
* Implement and manage change control systems for QC activities
including assessment of changes for impact and develop action plans
* Ensure appropriate procedures are in place by preparation and
review of SOP?s, methods, and specifications.
* Complete documentation reviews, reports, preparation, and trending
activities to ensure compliance
* Ensure QC activities are executed as prescribed by in-house
procedures and in compliance with requirements of cGMP and relevant
safety standards.
* Participating and follow-up the audits and/or inspections carried
out at the site by the authorities or clients
* Prepare and review QC department reports and metrics e.g. monthly
quality report, analysis trending reports, exceptions reports, KPI
reports, etc.
* Communicate to senior management on key events and issues etc. via
normal in-house reporting structure e.g. meetings, formal reports,
etc.
* Develop technical specifications and project justifications as
required
* Establish project schedule and key milestones
WHAT YOU NEED TO APPLY:
* 3rd level qualification in a relevant Science discipline
* Minimum 4 years of analytical experience in the pharmaceutical
industry with supervision experience essential.
* Proven track record in an analytical role. Must be expert in HPLC,
GC, LCMS, GCMS, Automatic titration, Identification techniques.
* Strong knowledge of regulatory requirements.
* Proficient in using analytical equipment in the QC lab.
* Involvement in product transfers/method transfer experience
preferred.
* Results-driven striving to meet all targets and metric standards
as set by department/site and division leaders.
* Applicant Name*
* Applicant Email*
* Role You Are
Why you should apply:
* Join a company that has developed a stand-out culture of
innovation, inclusion and development, and consistently features as a
great place to work.
* Generous package with good base salary and benefits to including
but not limited to health insurance, pension and bonus.
* Join an organization who embrace diversity, equality and inclusion
and puts patients first.
* Work with innovative new technologies, in combination with the
depth of expertise that exists within the local workforce, that have
allowed our client to develop and deliver products and processes to
support their wider global needs. These range from small scale
clinical trial supply to large commercial manufacturing.
WHAT YOU WILL BE DOING:
* Allocate the work of the department to the QC staff to ensure
effective schedule adherence
* Supervise the work performed in the QC department and perform
annual appraisals of QC staff while insuring up to date training and
development
* Control products (raw materials, intermediates, and finished
products) by following procedures (general, specific, of analysis and
use, and qualification of equipment) so as to meet schedule demands
* Review analytical data and approve and release material as defined
in relevant procedures
* Coordinate and manage equipment maintenance and repair activities
* Deliver operating budgets, ordering, and supervise expenditure
* Maintain an awareness of technical developments for
instrumentation analysis and schedule training for the team as
appropriate
* Perform investigations, and ensure a follow-up on anomalies,
failures, and external complaints
* Implement and manage change control systems for QC activities
including assessment of changes for impact and develop action plans
* Ensure appropriate procedures are in place by preparation and
review of SOP?s, methods, and specifications.
* Complete documentation reviews, reports, preparation, and trending
activities to ensure compliance
* Ensure QC activities are executed as prescribed by in-house
procedures and in compliance with requirements of cGMP and relevant
safety standards.
* Participating and follow-up the audits and/or inspections carried
out at the site by the authorities or clients
* Prepare and review QC department reports and metrics e.g. monthly
quality report, analysis trending reports, exceptions reports, KPI
reports, etc.
* Communicate to senior management on key events and issues etc. via
normal in-house reporting structure e.g. meetings, formal reports,
etc.
* Develop technical specifications and project justifications as
required
* Establish project schedule and key milestones
WHAT YOU NEED TO APPLY:
* 3rd level qualification in a relevant Science discipline
* Minimum 4 years of analytical experience in the pharmaceutical
industry with supervision experience essential.
* Proven track record in an analytical role. Must be expert in HPLC,
GC, LCMS, GCMS, Automatic titration, Identification techniques.
* Strong knowledge of regulatory requirements.
* Proficient in using analytical equipment in the QC lab.
* Involvement in product transfers/method transfer experience
preferred.
* Results-driven striving to meet all targets and metric standards
as set by department/site and division leaders.
* Applicant Name*
* Applicant Email*
* Role You Are
We need : English (Good)
Type: Permanent
Payment:
Category: Others
