Spot On for Talent Acquisition & Development

Process Expert 232 views

For our client in Stein we are looking for a Process Expert for a 2 months contract.

Place: Stein

Workload: 100%

Duration: asap- 31.12.2017

Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives Shop floor support:

  • Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements

Validation – execution and review of protocol/report:

  • Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution
  • Review and assure that validation protocols and report are technically correct
  • Ensure protocols are executed as intended Technical improvement execution:
  • Execute process improvements, scale-up
  • Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables

Primary packaging closure assessment during changes:

  • Evaluate and assure, in case of packaging change, that the primary packaging closure – including materials – are sufficient to ensure stability of the product and do not deteriorate quality

Assure consistency of Master Batch Records:

  • Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product

Deviation, Out Of Expectation, Out Of Specification, complaint handling:

  • Lead product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification
  • Use scientific and statistical knowledge to analyse data to provide process understanding, and to identify root causes of product and process failures Annual Product Reviews and Product Quality Reviews:
  • Be highly knowledgeable of product and process trends by providing input to

Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations

  • Be a resource to other departments as Subject Matter Expert for the product and process knowledge

Training:

  • Provide training for assigned new processes and products
  • Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position

Audit support:

Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit

Education (minimum/desirable):

  • in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
  • Desirable MSc. or equivalent experience.
  • Minimum 3 years experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).

Languages:

  • Fluent in English and proficient in site local language. Relevant Experiences:

Job Type: Contract

Only candidates can apply for this job.
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Company Information
  • Total Jobs 3601 Jobs
  • Category Recruitment Consultancy
  • Slogan We Stand Stronger When We Stand Together
  • Full Address Siedmiogrodzka 1/123 , 01-204 Warszawa
  • Address Warszawa
  • Industry Human Resources, Recruitment Consultancy, Training
  • Company Type LLC
  • Email enquiries@spotonps.com
  • SPOC enquiries@spotonps.com
  • About The Company Spot On was founded to help people find their dream job, and help employers find their dream candidates. We believe that social responsibility toward the community is an essential duty, ours is focused on finding the fit job for individuals with an Autism spectrum disorder (ASD) and people with impairment Surviving business environment is becoming more challenging than ever, which creates the need to possess all the skills necessary to grow the business and dominate market place. Unlike traditional recruitment and sourcing agencies, our focus is more on the talent acquisition process, it’s more about the proper identification of the skills needed and the recommendation of proper candidates. We are not just a recruitment company that’s after providing candidates and getting the revenue.  Our true focus is about minimizing the turnover rate of employees by identifying the needed skills, recommending the proper candidate and if needed, developing the needed skills in the candidate as well as the community through cooperation with governments and local entities.
  • Specialties Talent Acquisition and Development
  • Website https://spotonps.pl/
  • Headquarters Address Siedmiogrodzka 1/123
  • Tagline/Slogan We Stand Stronger When We Stand Together
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Contact US

Email : info@spotonps.pl
Address : Siedmiogrodzka 1 / 123, 01-204 Warszawa
Phone : +48 660 762 309

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