QC Operations Manager

Talentmark are recruiting for a QC OperationsManager to join a well-established and successful global pharmaceutical company based in Hatfield Hertfordshire on a permanent basis.

Role:

This role is responsible for the oversight of QC product testing (bulk and finished product) incoming goods testing and ensuring that all materials/bulk and finished product that require testing by the laboratory are done so according to agreed specifications and procedures and within agreed lead times.


Key duties will include:

• To approve QC testing conducted on bulk product stability and finished product and approve or reject starting materials or packaging component in accordance with Good Manufacturing Practices.
• Authoring checking or approval of documentation: SOPs LBPs spreadsheets methods reportsand protocols to ensure they are in conformance with Marketing or Clinical Trial Authorisations and / or regulatory expectations.
• Ensuring that all laboratory processes and equipment are covered by SOPs andensure that all equipment is covered by maintenance and calibration procedures.
• Leadinglaboratory investigations including those related to OOS or OOT analytical results ensuring they are investigated according to the agreed SOP and that any CAPAs are completed to agreed timelines.
• To manage all direct reports including any contractors to ensure that regular 1:1 meeting take place and that Job Descriptions Objectives and performance reviews are up to date and completed on time.
• To ensure efficient planning of all day to day activities conducted by the QC analysts and train staff for the QC functions.
• To coordinate and support testing for EU importation ensuring that a good working relationship is maintained with the contract laboratories and any issues/deviations are resolved.
• To support internal and external audits processes and audit schedules as appropriate andsupport the preparation and hosting of competent authority inspections.
• To support the implementation of change control activities and contribute to QC laboratory continuous improvement programme.

Your Background:

• Educated to degree level or above in a science discipline with significant previous experience in a QC Management role.
• Experience of leading and approving QC testing in GMP Pharmaceutical environment.
• Established people management experience and proven experience of directly managing analytical teams.
• Extensive knowledge of Quality Control Quality Assurance Quality Systems GMP Regulatory Compliance and manufacture and packaging of pharmaceutical products.
• Good technical and scientific judgement and the ability to interpret complex data and present key findings.
• Demonstrated Knowledge understanding and application of GMP Guidelines and Regulations.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197860 in all correspondence.































Competencies

• Demonstrable leadership and people management skills
• Problem solving and decision-making capabilities
• Professional behavior and self-awareness diplomatic
• Ability to motivate and influence self and teams
• High level of self-awareness
• Excellent communication skills
• Excellent presentation skills
• Effective time management

Employment Type : Full Time
Experience: years
Vacancy: 1