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Senior Manufacturing Compliance Engineer - Los Angeles, United States - Kindeva Drug Delivery
Description
Senior Manufacturing Compliance Engineer19901 Nordhoff St, Northridge, CA 91324, USA
Req #1209
05 April 2024
ROLE SUMMARY
The
Senior Manufacturing Compliance Engineer
position is recognized as an expert internally in the principles and application of quality assurance.
This role offers a unique opportunity to contribute your expertise and play a critical role in ensuring safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations, and established procedures.
This position will support inspection readiness and will collaborate with business owners to ensure compliance through periodic review of process, procedures, and policies.
ROLE RESPONSIBILITIES
The essential functions of the position may include but are not limited to:
Ensuring manufacturing operations and quality procedures for the area(s) are compliant to 21 CFR Part 210 and 211 requirements.
Conduct scientific, defensible investigations for any OOS, CAPA, or
QIR excursion.
Conduct and document Investigation promptly to support the
on-time closure of non-conformances to meet product fulfillment
dates.
Prepare root-cause and trend analysis to management during routine operation mechanisms (e.g. Management Review and CAPA Review Board).
Assists and supports the manufacturing staff in detecting and solving compliance errors in real time.
Assists in reviewing, editing, and authoring of SOPs / Master Batch Records and other technical documents.
Participate in continuous improvements of department processes.
Participate in inspection readiness and support activities
Participate in internal audit activities and help drive the closure of any observations.
Participate in process improvement initiatives (as necessary).
Tracking, trending, and reporting of compliance key performance indicators (training/QIRs) to Management.
BASIC QUALIFICATIONS
Education:
Communication:
Proficient in word, excel, and Microsoft applications.
Success in Role:
19901 Nordhoff St, Northridge, CA 91324, USA
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