Job Description

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Lead Validation Officer

Advertiser: Lipa Pharmaceuticals LtdMore jobs from this company

Job Information

Job Listing Date
8 Mar 2019
Location
Sydney, South West & M5 Corridor
Work Type
Full Time
Classification
Manufacturing, Transport & Logistics, Quality Assurance & Control

Lead Validation Officer

Lipa Pharmaceuticals Ltd is a successful contract manufacturer of complementary medicines in South West Sydney, with easy access via the M5 and M7 motorways.

We are looking for a dynamic and self-motivated professional to join our Quality Assurance department as a Lead Validation Specialist.

As the Lead Validation Specialist, you will be responsible for the planning, coordination and timely execution of all equipment, process and cleaning validation activities to ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. As the Lead Validation Specialist you will also be responsible for the overall coordination and leadership of the validation team.

Qualifications, knowledge, skills and experience:

  • B.Sc. (or higher degree) in a relevant scientific or engineering discipline; other formal qualifications maybe considered acceptable if supported by pertinent experience.
  • Minimum of 5 years related experience in a pharmaceutical or a similarly regulated environment, including hands on experience with DQ, IQ, OQ and PQ activities.
  • Must have a good understanding of the current PIC/S Guide to GMP for Medicinal Products requirements for validation activities, especially Annex 15 (Qualification and Validation) and relevant parts of Annex 11(Computerised Systems).
  • Possess a track record of achievement in meeting key performance indicators in a fast paced, customer centric, dynamic environment. 
  • Exposure to inspections conducted by third parties including regulatory agencies.
  • Be a good communicator, with well-developed written and oral language skills as well as superior computer skills with mastery of Excel and statistical analysis capabilities.
  • Experience leading and coordinating small project teams with direct experience leading individual technical specialists.
  • Be self-driven, have capacity to multitask across a number of activities at any single time, be super organised and structured and be able to effectively and efficiently work and interact with multidisciplinary teams and individual functional specialists.

Key job responsibilities:

  • Applying Quality Risk Management principles, develop and implement procedures for evaluating validation requirements and establishing validation protocols for key equipment, as well as manufacturing and cleaning processes.
  • Develop and implement procedures for the commissioning of new equipment and systems
  • Execute validation protocols and ensure final validated reports meet regulatory requirements.
  • Leading, training and coaching other team members in validation activities.
  • Providing expert technical advice on equipment validation (EV), process validations (PV) and cleaning validations (CV) to senior manager and executives.

Salary negotiable - commensurate with experience and qualifications.

If you are confident that you could add value to our team and be a success within our company, apply now!

The successful candidate will be required to undergo police, medical and reference checks.

Candidates must possess FULL WORKING RIGHTS for Australia.

www.lipa.com.au

Lipa Pharmaceuticals Ltd is a successful contract manufacturer of complementary medicines in South West Sydney, with easy access via the M5 and M7 motorways.

We are looking for a dynamic and self-motivated professional to join our Quality Assurance department as a Lead Validation Specialist.

As the Lead Validation Specialist, you will be responsible for the planning, coordination and timely execution of all equipment, process and cleaning validation activities to ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. As the Lead Validation Specialist you will also be responsible for the overall coordination and leadership of the validation team.

Qualifications, knowledge, skills and experience:

  • B.Sc. (or higher degree) in a relevant scientific or engineering discipline; other formal qualifications maybe considered acceptable if supported by pertinent experience.
  • Minimum of 5 years related experience in a pharmaceutical or a similarly regulated environment, including hands on experience with DQ, IQ, OQ and PQ activities.
  • Must have a good understanding of the current PIC/S Guide to GMP for Medicinal Products requirements for validation activities, especially Annex 15 (Qualification and Validation) and relevant parts of Annex 11(Computerised Systems).
  • Possess a track record of achievement in meeting key performance indicators in a fast paced, customer centric, dynamic environment. 
  • Exposure to inspections conducted by third parties including regulatory agencies.
  • Be a good communicator, with well-developed written and oral language skills as well as superior computer skills with mastery of Excel and statistical analysis capabilities.
  • Experience leading and coordinating small project teams with direct experience leading individual technical specialists.
  • Be self-driven, have capacity to multitask across a number of activities at any single time, be super organised and structured and be able to effectively and efficiently work and interact with multidisciplinary teams and individual functional specialists.

Key job responsibilities:

  • Applying Quality Risk Management principles, develop and implement procedures for evaluating validation requirements and establishing validation protocols for key equipment, as well as manufacturing and cleaning processes.
  • Develop and implement procedures for the commissioning of new equipment and systems
  • Execute validation protocols and ensure final validated reports meet regulatory requirements.
  • Leading, training and coaching other team members in validation activities.
  • Providing expert technical advice on equipment validation (EV), process validations (PV) and cleaning validations (CV) to senior manager and executives.

Salary negotiable - commensurate with experience and qualifications.

If you are confident that you could add value to our team and be a success within our company, apply now!

The successful candidate will be required to undergo police, medical and reference checks.

Candidates must possess FULL WORKING RIGHTS for Australia.

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