Senior Quality Assurance Officer

Overview

We have an exciting opportunity for a Senior Quality Assurance (QA) Officer to join our dynamic QA technical team where our mission is to ensure patient safety by maintaining the highest quality standards.

We are passionate about quality, we manage risks, ensure compliance, and strive for excellence in pharmaceutical manufacturing.

Compliance and quality are key in our industry so ensuring our processes and systems are compliant and controlled is essential.

You will work with all aspects of cGMP whilst compiling, reviewing and approving documents.

What you\'ll do

Perform actions required by the Quality Management Systems :

Develop, review and approve standard operating procedures

Review and approve change controls both internally and from 3 rd party manufacturers and packers.

Execute actions allocated to QA Technical team for change control management.

Compile product quality reviews in accordance with standard operating procedures, identify improvements and co-ordinate corrective actions

Lead, participate and review risk assessments

Lead, participate in quality event / deviation and customer complaint investigations (root cause analysis)

Review and assess vendor compliance in accordance with supplier qualification procedures

Participate in external and internal audits as required.

Compile technical reports in line with standard operating procedures

Review and approve all technical documentation relating to validation i.e URS, system risk assessments, facility / equipment / utility validation and qualification, technology transfer, analytical method validation, cleaning validation, computerised system validation, periodic reviews

Review and approve master batch manufacturing and packing documents when required for internal and 3 rd party manufactured and packed products

Manage allocated projects as and when required.

QA special point of contact for allocated customers and CMOs - co-ordinate documentation requests, queries, change controls, deviations / quality events

Promote quality culture within the organisation, identify and implement continuous improvement solutions.

Ensure compliance with company training programmes and take an active role in self-development.

What you\'ll bring

QUALIFIED EXPERT -

Tertiary qualification in Science, or similar.

QUALITYEXPERTISE -

Strong knowledge of GMP, regulations, and experience with Quality Management Systems.

Experience in writing and reviewing technical documents, risk assessments, root cause analysis.

You have experience documenting procedures, technical writing and validation documentation review.

You have a high level of attention to detail, risk-based thinking and excellent problem-solving skills

COLABORATION -

you are a proactive person who enjoys building relationships and finding solutions with a positive, quality-oriented mind-set.

CONTINUOUS IMPROVEMENT -

vision to see where we can improve and how to get us there.

COMMUNICATION -

you will have excellent communication skills and the ability to influence outcomes.

You are systems orientated; in both MS Office and have knowledge of or worked with document management systems.

Are you a quality ambassador?

So are we!

We partner pragmatically across the business to make things happen.

We keep the customer / patient at the centre of what we do, and coach others across the business on why quality matters.

Award-winning culture

• Join a team that\'s genuinely a great place to work (and we\'ve got the awards to prove it).

Career growth

Extra leave

Parental perks

Security matters

Feel good with THRIVE

Exclusive discounts

About Douglas

At Douglas, we\'re more than just a company—we\'re a community of people driven to make a difference.

We\'re proud to be one of New Zealand\'s biggest pharmaceutical success stories, and we\'re growing globally.

Privately owned and future-focused, our team of 700 includes scientists, engineers, and all kinds of experts, working together to create high-quality healthcare products that help people around the world.

Come join us on this mission to improve lives!

Next steps

If you\'re invited to complete a video interview as the next stage of your application, we\'d love you to embrace it.

Video interviews allow more people the opportunity to demonstrate their abilities to the hiring manager in a new and innovative way, giving you a better chance of securing your ideal role.

Relax, be yourself and don\'t worry, we all feel a bit awkward in front of the camera.

Please note, applications may close early due to high interest.

Don\'t miss out - apply now!

Job Details

Reference

16511

Expertise

Analysis and Reporting, Auditing, Compliance and Risk, Manufacturing / Production, Machine Operators, Production Operators, Trainee Operators, Team Leaders / Supervisors, Management, Science and Technology, Chemistry, Formulation, Laboratory, Laboratory and Technical Services, Microbiology, Quality Assurance, Quality Control, Research and Development

Job Level

Experienced

Location

West Auckland

Work Type

Permanent full-time

Application Closes

17 Oct : 00

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