Quality Control Supervisor

PE Global; Sligo; On-site; EUR 52,000 - 72,000; Full time

Job summary

PE Global is recruiting a Quality Control Supervisor for a leading multinational pharma client in Sligo on a contract basis. You will supervise assigned QC activities, coach analysts, ensure data integrity and regulatory compliance, and drive improvements in testing and documentation.

The role covers materials, in-process, finished product analysis and transfers, with close collaboration to the Laboratory Manager and CI initiatives.

Qualifications

• 3rd level qualification in a relevant Science discipline.
• Minimum 4 years analytical experience in the pharmaceutical industry.
• Proven track record in an analytical role. 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.

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 in the assigned cell or team perform to the best of their ability, coaching and guiding where issues occur.
• Improving efficiency and velocity within the assigned team.
• Identifying and implementing improvements in analytical practices such as poke yokes.
• Ensuring test schedules are adhered to and recoveries are identified to maintain plant alignment.
• Identifying weaknesses in laboratory performance and working with the Laboratory manager to rectify.
• Acting as designee for the Laboratory Manager as assigned.
• Ensuring 6S excellence across the Laboratory.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team.

Skills

HPLC

GC

LCMS

GCMS

Titration

Regulatory know-how

Tech transfer

Education

3rd level qualification in Science

Job description

PE Global is currently recruiting for a Quality Control Supervisor for a leading multi-national Pharma client based in Sligo.

This is a contract position.

Role:

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 as 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 of 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.

Requirements:

• 3rd level qualification in a relevant Science discipline.
• 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.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***