Night-Shift Pharma Production Supervisor - Global CMO

Location
Madrid
Salary
€30000 - €35000 per annum
Posted
Jun 16, 2017
Closes
Jul 16, 2017
Ref
RW.160962.03
Contact
Ruby Wallace
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

This is a cross functional position encompassing, but not limited to the Supervision of the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Sterile manufacturing processes. But will focus on a range of dosage forms - Liquid, Aseptic, Solid and Dry powers.

This will be for a NIGHT SHIFT - you will be in charge of the WHOLE sites production area - Approximately 50 members of staff.

Responsibilities:

  • Reports to manufacturing upper management.
  • Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
  • Comprehends and adheres to all cGMP's and other Regulatory requirements.
  • Respond to questions from outside regulatory agencies including the FDA, DEA.
  • Comprehends and adheres to all related SOP's as well as Batch Records and Protocols.
  • Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
  • Completes all required Training activities.
  • Clearly and accurately completes all required GMP documentation.
  • Perform Room and Equipment inspections and completes all pertinent documentation.
  • Manual Dexterity is required.
  • Other duties as assigned

POSITION QUALIFICATIONS

  • Has authority for personnel actions and oversees most day to day operations of various unit operations within the Dosage Forms area.
  • Perform work in compliance with established cGMP and SOPs.
  • Respond to questions from outside regulatory agencies including the FDA, DEA.
  • May be responsible for the receipt, storage and issuance of all Controlled Substance material activities within the Dosage Forms area.
  • Generates Demand Work Orders as needed.
  • Establishes or revises SOP's as required.
  • Initiates Planned and Unplanned Deviations as required.
  • Schedules and assigns manufacturing personnel to their daily job assignments.
  • Evaluates for disposition employee Paid Time Off requests.
  • Secures quotes and arranges for vendor service calls as needed.
  • Orders supplies for the department as needed.
  • Generates employee Performance Appraisals and Disciplinary documentation.
  • Computes amounts of materials and supplies required for operations, based on production schedules, and requisitions or directs the requisition of materials from storage areas.
  • Plans flow of materials through the department and plans work according to manufacturing schedule.
  • Interfaces with others in the organization as well as clients to ensure customer deadlines are met.
  • Inspects and approves manufacturing rooms and equipment for cleanliness and completes the required documentation.
  • Manages and schedules employee overtime as needed.
  • Directs workers in adjusting machines and equipment to meet required specifications.
  • Performs batch record reviews prior to disposition.
  • Develops, recommends, and implements measures to improve production methods, equipment performance, and quality of product.
  • Analyzes and resolves work problems, or assists workers in solving work problems.

EXPERIENCE:

  • Three to five years related experience and/or training; or equivalent combination of education and experience.
  • Fluent in Spanish/ English
  • Experienced interaction with regulatory agencies including the FDA, DEA.
  • Solid understanding of cGMP practices and concepts.
  • Mechanically inclined candidates are preferred.

Location: Madrid, Spain

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 02079402105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

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