Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale we are committed to delivering at the highest quality. Its inspiring and rewarding work influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make peoples lives better from patients and their families to all of us in society.

THIS POSITION IS FOR 3rd SHIFT: M-F 10pm - 6:30am.

Accountabilities

Support specific Quality Operations processes within assigned area:
External Audit Readiness - support the preparation activities for internal and external inspections including FDA EMA and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits inspections and response process as applicable.
Self Inspection Program Assist in developing and driving the sites annual self inspection plan to ensure Quality standards are being met in advance of external regulatory audits.
Batch Record Review/Approval act as the final signatory on production records to protect data integrity and right first time execution of the production records. Partner with operations teams to remediate errors and improve execution of production standards.
Line Clearance and Oversight conduct daily walk through inspections (GENBA) of the Aseptic Filling Pack Operations and supporting areas throughout the facility to confirm GMP processes and standards are followed.
Validation Review/Approval support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design
Work cross functionally with other Quality teams to support:
o Acceptable Quality Limit (AQL) Inspections
o Deviation Investigations and CAPA Planning
o Quality Risk Management
o Product Complaint Investigations
o Change Control Planning and Execution
o GDP Data Review and Trending
Partner and support operations functions related to Quality standards and regulatory expectations.
Provide mentorship and support to cross-functional teams in risk management compliance and sharing valuable observations and findings.
Lead and implement simplification and improvement initiatives in collaboration with other quality assurance colleagues.
Help update training content and support training sessions focused on quality standards compliance and inspection preparation for staff at various levels.
Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.

Required Skills/Experience
Bachelors degree in a Science / technical field such as Pharmacy Biology or Chemistry
3 years experience within pharmaceutical manufacturing and quality
Strong orientation for continuous improvement and process streamlining and optimization.
Experience applying Lean principles and motivating change initiatives within a structured framework.
Self-motivated individual that works independently.
Effective communication and interpersonal skills are required.

Desirable Skills/Experience
Project management experience
Lean manufacturing experience
Some experience in business process/ quality system management.
Knowledge of/ experience with newer digital tools and technologies related to quality systems management.
Regulatory and compliance experience with an organization such as FDA MHRA EMA ANVISA HC and KFDA.

At AstraZeneca we are driven by a strong connection to our patients. Our mission is to find the best solutions to put our patients first. Here you will play a critical role in delivering innovative medicines all the way until they reach our patients. We grow with challenges continuously seeking new ways to deliver life-changing medicines. Our collaborative environment encourages sharing ideas and problem-solving as a team. With constant new products and launches there has never been a better time to join us.

Ready to make a big impact Apply now!

Date Posted

Closing Date