Quality & Compliance Specialist

Company: Piramal Pharma Solutions
Location: Riverview
Posted on: May 16, 2022

Job Description:

POSITION SUMMARY: 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. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. Identify and protect the original technical information as part of the company property. 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. job conditions. The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands : Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer. Work Environment : Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

Keywords: Piramal Pharma Solutions, Detroit , Quality & Compliance Specialist, Other , Riverview, Michigan