Quality and Compliance Specialist

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Quality and Compliance Specialist

Job Description

Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality and Compliance Specialist to join our Quality Control team. The Quality and Compliance Specialist is responsible for the review of the laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP and data integrity standards. They are responsible for the release of some GMP materials.

Key responsibilities.

• Review IPC, raw materials, intermediates, and finished products analytical data, as well as cleaning validation/verification data according to cGMP, GDP, in a timely manner.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing
• Interface with their supervisor, the analytical group(s) and QA on a daily basis.
• Review of deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations
• Document review includes review of sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms, and electronic data and audit trails
• Review of a variety of data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing
• Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.
• Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
• Assist in the preparation of new or revised documentation as required.
• Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
• Revise via change control documentation as required
• Perform other related assignments and projects as required

EDUCATION/EXPERIENCE.

• Bachelor's degree in Chemistry, Biochemistry or related field.
• Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques. QC data review experience a plus.
• Knowledge of ECM OpenLab, SAP, Trackwise, LIMS a plus.
• Technical Writing Experience
• Minimum two (2) years of GMP laboratory experience.

job competencies.

• Ability to monitor, coordinate and prioritize work in an effective and efficient manner.
• Must be a self-motivated, proactive team member to manage work within quality projects and timelines.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• High attention to detail.