QC Supervisor

Orion Group Life Sciences are currently recruiting a QC Supervisor on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 12-Month contract with potential to extend.
 
Purpose:
To provide effective testing and analytical service to the plant ensuring that products
manufactured are tested to specification on time and plant quality and safety goals are
met.
 
Ensure that all raw materials, in-process, finished product, stability and contract testing
and is carried out per schedule and records are maintained to appropriate requirements.
Ensure that technical and systems excellence is maintained in the laboratory by ensuring
own skills are maintained by coaching and training analysts to ensure right first time
behavior and by implementing improved working practices in terms of efficiency,
compliance and Right First Time.
This position will take full responsibility for an assigned segment of the QC operation
for example, Raw Materials & Drug Product Analysis or In-process & API.
 
Responsibilities:

• Ensure Laboratory Documentation and Computerized Systems compliance with

Data Integrity policies and regulatory requirements.

• Understand Regulations and business processes required to maintain Laboratory

Data Integrity.

• Ensuring timely completion of all laboratory analysis assigned.
• Ensuring that analysts working in the assigned cell or team are performing to the

best of their ability, coaching and providing guidance where issues occur such as
poor set-up or test execution performance.

• Improving the overall efficiency and velocity within the assigned team.
• Identifying and implementing improvements in analytical practices such as poke

yokes.

• Ensuring that the agreed test schedule is adhered to and identifying recovery paths

to bring test schedules back into alignment with plant requirements.

• Identifying weaknesses in laboratory performance and working with the laboratory

manager to rectify.

• Resolving analytical OOS issues as they arise in a timely manner both through

practical work and through Soltraqs.

• Acting as designee for the Laboratory Manager as assigned.
• Ensuring 6S excellence is maintained across the Laboratory.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory

team

• Ensuring that all laboratory test equipment is utilised and maintained correctly.
• Executing and / or supporting projects assigned by the laboratory manager.
• Maintaining up-to-date, complete and precise records of all tests performed.
• Acting as the primary point of contact for any analytical issues which arise.
• Developing expertise and understanding of current and future analytical techniques.
• Developing and changing in-house laboratory procedures as appropriate.
• Carrying out verification of testing records as necessary.
• Positively contribute to departmental programs such as CI, BEx and RFT.
• Supports the transfer of new products.
• Completes project work.
• Adheres to and supports all EHS & E standards, procedures and policies.

 
Supervision Received

• Operates in an environment which is essentially self-managed but with supervision

through the Laboratory Manager.

• Analytical Chemist will liaise with the QC coordinator and QC technical trainer to

meet department testing timelines.

• Goals are reviewed on a regular basis

 
Supervision Provided

• Provides supervision to 1-2 Direct reports.
• Is responsible for setting annual goals, completing reviews, growth plans and

performance management of the team.
 
Qualifications:

• 3rd level qualification in a relevant Science discipline.

 
Job/Technical Skills

• Minimum 4 years analytical experience in the pharmaceutical industry.
• Proven track record in an analytical role. Must be expert in HPLC, GC, LCMS,

GCMS, Automatic titration, Identification techniques.

• Strong knowledge on regulatory requirements.
• Proficient in using analytical equipment in the QC lab.
• Involvement in product transfers / method transfer experience preferred.

 
Cognitive/Business Skills

• Requires a high level of attention to detail and mental concentration, to ensure

accuracy and total compliance with procedures.

• Requires innovative thinking, where new and untested solutions are proposed,

demonstrated and implemented on a regular basis.

• Requires proven problem-solving skills and the ability to adapt to new requirements.
• Is results driven striving to meet all targets and metric standards as set by

department/site and division leaders.

• Prioritises their own and their teams work in line with business demands.
• Requires total commitment to quality and maintaining a high standard of work at all

times.

• Demonstrates the highest levels of integrity and a strong work ethic at all times.
• Strong communication skills, both verbal and written, are required for the execution

of this role.

• Strong interpersonal skills are required.
• Supports the principles of Perfect Performance.

 
Ownership/Accountability

• Responsible for the smooth and efficient running of the Laboratory and supervising

the work of the Laboratory Analysts.

• Responsible for presenting and taking ownership of own area during regulatory

inspections and corporate audits.

• Demonstrates tenancy in the closure of issues and meeting project deadlines.
• Must ensure that all work carried out meets cGMP standards and that all quality

records will meet inspection and audit scrutiny.

• Demonstrates an ethos of Right First Time at all times.
• Ensuring team compliance to procedures, policies and guidelines ensuring

adherence with cGMP and HPRA/FDA regulations and company policies,
procedures and guidelines as all times.
 
Influence/Leadership

• Leads and gives directions to the Laboratory Analysts group.
• Is a site SME on all Analytical issues and provides guidance on same.
• Contributes to the successful delivery of site C.J.R.s and Goals.
• Leads the delivery of new Analytical initiatives.
• Promotes department goals by selecting, motivating, and training capable staff.
• Leads the activities of assigned staff by communicating and providing guidance

towards achieving department objectives.

• Contributes to Talent Management of teams within the organisation and to the

development of the team to meet evolving business needs.
 
Decision Making/Impact

• Expected to handle all day-to-day incoming, in-process and final product testing and

analysis. If problems occur, the Analytical Chemist is required to investigate and
tackle independently.

• Responsible for the presentation of technical data to stakeholders to ensure prompt

decisions on Analytical related issues.
 
 


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