Manager, Quality Assurance
Company: Piramal Enterprises Ltd.
Posted on: June 10, 2021
POSITION SUMMARY: The Manager, Quality Assurance is responsible
for overall management of Quality Assurance operations. The
incumbent ensures that Quality Assurance (QA) activities are
conducted in compliance with Current Good Manufacturing Practices
(cGMP). Makes sure that all SOPs and applicable regulations are
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 regulatory requirements, including FDA,
EPA, OSHA, and related safety, health and environmental procedures,
policies and practices.
- Consistent support and practice of all Ash Stevens' mission and
The Incumbent will be primarily responsible to ensure the
Quality Assurance team ensures the following by mentoring and
managing the team members appropriately:
- Review of batch production records (including analytical test
packages, cleaning records, etc.: The incumbent's primary
responsibility will be to ensure that batches meet GMP requirements
and are manufactured according to approved Standard Operating
Procedures (SOP), finished products meet specifications before
releasing it to the client, and appropriate resolution to batches
pending approval due to GMP errors and related corrective action
investigations. Review in-process batch records, finished product
batch records and intermediate analytical records. Release raw
materials, starting materials, intermediate products, and final
Active Pharmaceutical Ingredient (API) based upon conformance with
specifications and completion of associated documents. In addition,
when shipments of final API are made, verify labeling and packaging
is consistent with Ash Stevens' SOP.
- Administrative Duties: Issue master production records to
manufacturing, ensuring that the current version is issued. File
completed batch production records, testing records, and cleaning
records. Maintain change control files for master records, SOPs,
and forms. Ensure that current versions of the records are properly
filed and available for use by the end users.
- Audits: Support internal and external audits and regulatory
inspections. This may require data gathering, interviewing or
escorting auditors during an audit. Conduct internal audits and
housekeeping inspections and walkthroughs of Ash Stevens Quality
Systems and related operations to ensure compliance with written
procedures. Audits quality system and records, creating
documentation as needed. Follow-up as appropriate to ensure
corrective action is implemented. During an audit of Ash Stevens,
participate in the audit to explain Ash Stevens' quality systems
and operations. The incumbent is expected to represent Ash Stevens'
systems thoroughly and positively, being receptive to the auditor's
comments. Participate in the development of a formal response to
audit report as appropriate. Maintain QA retain inventory and
perform annual retain inspections.
- Reports/Document Management: This may include Annual Product
Reviews, Non-Conforming Material Reports, and Investigation
Reports. Participate in preparation or review of associated
documentation, such as Analytical Methods Validation Reports,
Cleaning Validation Reports, and Process Validation Reports.
- Quality Systems Support: Support tracking of Quality System
deliverables, i.e. CAPA's, periodic document review, environmental
monitoring, Quality Metrics, Quality Agreements etc. Review and
approve TrackWise events related to manufacturing, laboratory and
warehouse operations. Participate in the evaluation and triage of
events, deviations, CAPA's, OOS, OOT and unplanned maintenance
activities. Identify and implement continuous improvements for the
elements of the quality system related to manufacturing, laboratory
and warehouse operations. Contribute to the writing, coordination,
review, approval and maintenance of the standard operating
procedures, policies and work instructions. Conduct Gap Assessments
with corporate guidelines and regulatory requirements and develop
- Metrics: Perform routine and adhoc Quality Systems Metric
Reporting and analysis for the local site data. Prepare metrics and
perform trend analysis in support of management review.
- Risk Management: Participate in the Risk Management program,
including updating risk analysis, participating in applicable teams
and maintaining Risk Management documents.
- Training: Participate in training of Ash Stevens team members
and in documentation and maintenance of training files. Conduct
training activities related to QA operations and quality systems.
Develop and maintain training modules.
- Bachelor's degree in the physical or biological sciences or
engineering. Chemistry/Chemical Engineering preferred.
- Minimum eight (8) years' experience in pharmaceutical
operations, regulated life sciences, or quality assurance is
preferred with 2-5 years of supervisory experience.
- Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex
11 and ICH Q7, Q9 & Q10).
- Strong computer skills with MS Office (e.g. Word, Visio and
Excel), Relational Databases, Reporting and statistical tools.
- Proficient in TrackWise, SAP and Master Control.
- Excellent organizational and planning skills.
- Strong written, verbal, and interpersonal communication
- Have the ability to develop, perform, evaluate, and
troubleshoot within a scientific discipline.
- Demonstrated strong analytical skills, and the ability to work
independently against multiple deadlines.
- Experience interacting with FDA or other regulatory
- Knowledge with manufacturing quality (manufacturing, packaging,
facilities, critical systems, validation, SPC, etc.)
- Must complete tasks independently and notify supervisor of
decisions outside of established processes.
Physical demands and work environment:
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.
Keywords: Piramal Enterprises Ltd., Fargo , Manager, Quality Assurance, Other , Michigan, North Dakota
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