Quality and Compliance Specialist

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions’ Ash Stevens facility in Riverview, MI seeks a Quality and Compliance Specialist to join the Quality Control team. You will review laboratory data to ensure methods and procedures meet GMP and data integrity standards.

Responsibilities include reviewing HPLC/GC data, releasing materials, and supporting investigations and continuous improvement initiatives within a GMP environment.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• 2–5 years of experience using HPLC, GC, or related analytical techniques.
• QC data review experience a plus.
• Knowledge of ECM OpenLab, SAP, Trackwise, LIMS is a plus.
• Technical writing experience; GMP laboratory experience.

Responsibilities

• Review IPC, raw materials, intermediates, and finished products data per cGMP.
• Release starting materials and cleaning validations for GMP manufacturing.
• Review deviations for accuracy and data integrity.
• Review reports such as method validation, stability, and calibration records.
• Support investigations (OOS, deviations, CAPAs) and audits.

Skills

GMP laboratory experience

HPLC

GC

Data review

Technical writing

Education

Bachelor's degree in Chemistry/Biochemistry or related field

Tools

ECM OpenLab

SAP

Trackwise

LIMS

Job description

Be the First to Apply 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.