Job Description

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Senior Validation Officer

Advertiser: Lipa Pharmaceuticals LtdMore jobs from this company

Job Information

Job Listing Date
16 Jun 2018
Location
Sydney, South West & M5 Corridor
Work Type
Full Time
Classification
Science & Technology, Quality Assurance & Control

Senior Validation Officer

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

Currently we are looking for a dynamic and self-motivated person to join Lipa’s Quality Assurance Team as Senior Validation Officer.

As the Senior Validation Officer, you will be responsible to plan, coordinate and control all validation activities and related QA Systems, across the company to the required company and regulatory standards.

The successful candidate will need to demonstrate the following attributes and experience.

  • To have an understanding of GMP requirements for validation activities, especially Annex 15 (Qualification and validation) and relevant parts of Annex 11(Computerized systems) of the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products
  • To be able to apply Quality Risk Management in validation activities
  • To establish scope and schedule of validation activities
  • Ensure the team’s targets are enforced and achieved
  • Develop and implement procedures for evaluating validation requirements and establishing validation protocols for equipment and systems
  • Develop and implement procedures for validating equipment and systems
  • Develop and implement procedures for commissioning of new equipment and systems
  • Execute validation protocols
  • Develop validation final reports summarizing executed validation
  • Review existing documentation to determine relevance and level of completeness
  • Ability to meet deadlines and work under conflicting time pressures
  • Have exceptional spoken and written communication skills with capacity to prioritize, organize, lead and deliver results in a team environment.
  • Ability to train other team members in relevant validation activities
  • Provide advice relevant to validation requirements to management as required
  • To be involved in inspections as required
  • Demonstrate initiative, yet able to follow instructions and procedures
  • Strong personal organisational skills
  • Well developed communication skills
  • Commitment to WHS practices and procedures
  • Minimum of 5 years related experience in a pharmaceutical or similar cGMP environment
  • Bachelors degree in a scientific or engineering discipline or equivalent

Salary negotiable- commensurate with experience and qualifications.

If you are confident that you could measure up to our expectations, email your applications to:
hr@lipa.com.au

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 OTC and complementary products in South West Sydney with easy access via the M5 and M7 motorways.

Currently we are looking for a dynamic and self-motivated person to join Lipa’s Quality Assurance Team as Senior Validation Officer.

As the Senior Validation Officer, you will be responsible to plan, coordinate and control all validation activities and related QA Systems, across the company to the required company and regulatory standards.

The successful candidate will need to demonstrate the following attributes and experience.

  • To have an understanding of GMP requirements for validation activities, especially Annex 15 (Qualification and validation) and relevant parts of Annex 11(Computerized systems) of the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products
  • To be able to apply Quality Risk Management in validation activities
  • To establish scope and schedule of validation activities
  • Ensure the team’s targets are enforced and achieved
  • Develop and implement procedures for evaluating validation requirements and establishing validation protocols for equipment and systems
  • Develop and implement procedures for validating equipment and systems
  • Develop and implement procedures for commissioning of new equipment and systems
  • Execute validation protocols
  • Develop validation final reports summarizing executed validation
  • Review existing documentation to determine relevance and level of completeness
  • Ability to meet deadlines and work under conflicting time pressures
  • Have exceptional spoken and written communication skills with capacity to prioritize, organize, lead and deliver results in a team environment.
  • Ability to train other team members in relevant validation activities
  • Provide advice relevant to validation requirements to management as required
  • To be involved in inspections as required
  • Demonstrate initiative, yet able to follow instructions and procedures
  • Strong personal organisational skills
  • Well developed communication skills
  • Commitment to WHS practices and procedures
  • Minimum of 5 years related experience in a pharmaceutical or similar cGMP environment
  • Bachelors degree in a scientific or engineering discipline or equivalent

Salary negotiable- commensurate with experience and qualifications.

If you are confident that you could measure up to our expectations, email your applications to:
hr@lipa.com.au

Successful candidate will be required to undergo Police, Medical and reference checks.

Candidates must possess FULL WORKING RIGHTS for Australia.
 

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