Head of Production - Mablethorpe, United Kingdom - Crescent Pharma

Crescent Pharma

Verified Company

Mablethorpe, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Job description

£40,000 - £50,000 depending on experience, No Weekends or Bank Holidays

25 days holiday (excluding Bank Holidays)

JOB PURPOSE:

The Head of Production will manage a team of Production Managers and their allocated teams to produce finished products, with GMP compliance and in compliance with SOPs. He/she should be able to delegate the tasks to appropriate team members to provide quality output within tight deadlines. The monitoring and control of the manufacturing environment;
Plant hygiene;
Process validation;
Training;
The approval and monitoring of suppliers of materials;
The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
The designation and monitoring of storage conditions for materials and products;
The retention of records;
The monitoring of compliance with the requirements of Good Manufacturing Practice;
The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

PRINCIPAL ACCOUNTABILITIES:

Assist in the development and implementation of standard operating procedures and assist with quality standards.
Review and approval of operational SOPs
Be consulted with regard to Technical agreements being in place
Provide guidance and support on quality matters to internal customers.
Take responsibility for any production applicable queries arising from customer complaints in compliance with Thorpes SOPs.
Perform internal selfinspections.
Involved in external parties audits of the company.
Work with and complete when required, quality documentation including SOP, specifications, GMP records, batch documentation.
Assist in the development and implementation of standard operating procedures and assist with quality standards.
Review and approval of operational SOPs
Be consulted with regard to Technical agreements being in place
Provide guidance and support on quality matters to internal customers.
Take responsibility for any production applicable queries arising from customer complaints in compliance with Crescent Manufacturing SOPs.
Participate in the Change Control, Process Deviation and Customer Complaint Handling process.
Perform internal selfinspections.
Involved in external parties audits of the company.

PLANNING, ORGANISING AND CONTROLLING:

Supervise and coordinate activities of Production managers and their teams in production of finished products to ensure compliance with GMP and the SOPs that the company currently has in place.
Deal with personnel issues in a professional and consistent manner, using the correct line of management and the assistance of Human Resources, when required.
Regularly assess the work to ensure good communication and flow of jobs between planning department and the shop floor.
Collect, update and analyse the output figures and other statistics, as and when required.
Ensure PBRs/BMRs are processed correctly and in a timely manner.
In addition to the above responsibilities Production Manager is also responsible for the following:
Acknowledge team's expertise and experience. Liaising with Production Managers to organise the necessary training to ensure all skill gaps are completed.
Proactively seek ways to improve the efficiency of the setup, layout or organisation of areas, equipment, documentation, personnel and /or materials as appropriate.
Assure production activities are performed in line with budget.
Make recommendations for production activities that may need to be budgeted in future years.
Regular contacts with suppliers, clients and Supply chain.
Regular contact with colleagues with the QA/QC/Regulatory Affairs teams.

CONTACT WITH OTHERS:

Internal
QA

Regulatory

Supply Chain / Planning

Customer Services

Warehouse

Sales & Marketing

External
Third Party Sub-contractors (EU and Non-EU)

Regulatory / QP Consultants

Customers

MAJOR CHALLENGE OF THE JOB:

To assist in the maintenance of existing quality standards in line with company policies and regulatory guidelines, to ensure the quality of Thorpes products and sub-contractors.

KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED:

Educated to degree Level standard, or equivalent. A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or Biology would be desirable.
Effective time management skills with a flexible approach and the ability to adapt quickly to changing priorities.
Selfmotivated and organised with ability to work using own initiative and as a team.
Good attention to detail and ability to follow defined procedures and regulatory guidelines.
Excellent interp