
Quality Management Specialist
3 days ago
Domnic Lewis has been mandated to hire for the role- Manager – QA (QMS)with a renowned pharma company on Contract PayrollPayroll company- Domnic LewisContract Period- 6 to 8 months
Experience: 8 to 14 years
Qualification: B. Pharma / M. Pharma / M.Sc. (Chemistry)Shift: The selected candidate will support one of our sites in North America and will be required to work as per the US time zone. Job Overview:We are seeking a highly skilled and experienced Manager – QA (QMS) to lead and support Quality Management System (QMS) activities in a regulated pharmaceutical environment.
The ideal candidate will have deep expertise in quality control investigations, quality compliance processes, and strong familiarity with oral solid dosage (OSD) formulations and/or API manufacturing. Key Responsibilities:Lead and review Quality Control investigations such as OOS (Out of Specification), OOT (Out of Trend), Lab Incidents, and DeviationsConduct Root Cause Analysis and Risk Assessments to identify and mitigate potential quality issues
Provide oversight on compendia assessments and ensure alignment with current pharmacopeial requirements
Draft and manage Quality Technical Agreements (QTA) with external and internal stakeholders
Analyze and trend data for Annual Product Quality Reviews (APQR)Review and support Process Validation, Cleaning Validation, and Equipment Qualification documentation and activities
Collaborate with cross-functional teams to ensure timely resolution of quality-related issues
Ensure compliance with regulatory requirements and internal QMS standards
Maintain audit readiness and actively participate in internal/external audits and inspections
Required Experience & Skills:8–14 years of experience in pharmaceutical Quality AssuranceStrong understanding of OSD and/or API manufacturing processes
Hands-on experience with analytical instrumentation and common QC techniques
Excellent written and verbal communication skills
Proven track record in handling regulatory expectations and maintaining compliance in cGMP environments
Proficiency in QMS tools and electronic systems used in pharma environments
Desirable Attributes:Detail-oriented with strong organizational and documentation skills
Ability to work independently and manage multiple quality projects
Strong problem-solving and decision-making abilities
Experience in facing audits by regulatory agencies like USFDA, EMA, WHO, etc.Please share updated cv at ***********
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