Job Description

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Technical Writer - QA

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

Technical Writer - QA

ABOUT US

Lipa Pharmaceuticals Limited is a manufacturer of pharmaceutical and complementary products located in outer South West Sydney. Our company is seeking an experienced Technical Writer.

ABOUT THE ROLE

Working as part of the QA team, you will need to demonstrate the following attributes and experience:

  • Write detailed and accurate technical testing specification for all relevant products including but not limited to raw material and finished products as in line with latest updates in the BP/ USP/ EP and other relevant Pharmacopeia standards.
  • Write detailed and accurate technical finished product specification based on customer approved specification incorporating BP/ USP/ EP test procedures wherever applicable.
  •  Preparing and updating relevant QBI and TGO statements/guidances.
  • Reviewing and updating expired and or superseded documents within valid time frame.
  • Control the lifecycle of all relevant cGMP documents.
  • Review of the documentation and train laboratory staff for testing if required.
  • Co-ordinate distribution of controlled documents.
  • Liaise with regulatory affairs, laboratory staff and external customer’s regarding test methods and their ongoing documentation requirements
  • Report and monitor documentation progress.
  • Assist both internal and external customers in any queries regarding raw materials and finished products test methods.

For this role the ideal candidate will have recognised qualifications in Science supported by previous experience in a similar role in the pharmaceutical, complementary or similarly cGMP driven related industries. Your knowledge and understanding of quality systems as well as your attention to detail should be exceptional as must be your ability to work well in a collaborative team environment.

ABOUT YOU

Other attributes required are as follows:

  • Detailed understanding of British, EU and United States pharmacopoeia,
  • A solid work ethic with a desire to be a valued team contributor,
  • Sound understanding and commitment to GLP and GMP requirements in a strongly regulated environment,
  • Superior communication (written and spoken), presentation and influencing skills,
  • Outstanding organisational and task scheduling skills sets and capabilities,
  • Ability to meet deadlines and work under conflicting time pressures.


Please note: The successful candidate will be required to undergo Police, Medical and Reference checks. 

All applicants must possess FULL WORKING RIGHTS for Australia.

Only those deemed suitable by Lipa Pharmaceuticals will be contacted for interview.
 

 

 

www.lipa.com.au

ABOUT US

Lipa Pharmaceuticals Limited is a manufacturer of pharmaceutical and complementary products located in outer South West Sydney. Our company is seeking an experienced Technical Writer.

ABOUT THE ROLE

Working as part of the QA team, you will need to demonstrate the following attributes and experience:

  • Write detailed and accurate technical testing specification for all relevant products including but not limited to raw material and finished products as in line with latest updates in the BP/ USP/ EP and other relevant Pharmacopeia standards.
  • Write detailed and accurate technical finished product specification based on customer approved specification incorporating BP/ USP/ EP test procedures wherever applicable.
  •  Preparing and updating relevant QBI and TGO statements/guidances.
  • Reviewing and updating expired and or superseded documents within valid time frame.
  • Control the lifecycle of all relevant cGMP documents.
  • Review of the documentation and train laboratory staff for testing if required.
  • Co-ordinate distribution of controlled documents.
  • Liaise with regulatory affairs, laboratory staff and external customer’s regarding test methods and their ongoing documentation requirements
  • Report and monitor documentation progress.
  • Assist both internal and external customers in any queries regarding raw materials and finished products test methods.

For this role the ideal candidate will have recognised qualifications in Science supported by previous experience in a similar role in the pharmaceutical, complementary or similarly cGMP driven related industries. Your knowledge and understanding of quality systems as well as your attention to detail should be exceptional as must be your ability to work well in a collaborative team environment.

ABOUT YOU

Other attributes required are as follows:

  • Detailed understanding of British, EU and United States pharmacopoeia,
  • A solid work ethic with a desire to be a valued team contributor,
  • Sound understanding and commitment to GLP and GMP requirements in a strongly regulated environment,
  • Superior communication (written and spoken), presentation and influencing skills,
  • Outstanding organisational and task scheduling skills sets and capabilities,
  • Ability to meet deadlines and work under conflicting time pressures.


Please note: The successful candidate will be required to undergo Police, Medical and Reference checks. 

All applicants must possess FULL WORKING RIGHTS for Australia.

Only those deemed suitable by Lipa Pharmaceuticals will be contacted for interview.
 

 

 

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