Associate Director, Quality Assurance
1 week ago
Piramal Pharma Solutions is seeking an experienced Associate Director, Quality Assurance to provide quality operations support for both Clinical and Commercial Operations. The successful candidate will be responsible for data auditing, QA IT support, and leadership of quality operational activities.
Key Responsibilities- Provide quality operations support for Clinical and Commercial Operations
- Conduct data auditing for Quality Control operations
- Support QA IT for the site to ensure compliance with regulatory requirements
- Lead quality operational activities and provide leadership to clients
- Develop and implement operational metrics related to record execution
- Establish and track relevant KPIs
- Coordinate daily and monthly staffing schedules, capacity planning, and cross-training efforts
- Assist QA management with identifying staffing needs and contribute to hiring decisions
- Provide direction of CSV support needed for the site to ensure business continuity and support new equipment induction activities
- Support/execute Supplier Management Program and Annual Product Review
- Manage Departmental Budget
- Support, serve as Subject Matter Expert for internal, customer, and regulatory audits/inspections
- Execute system/process gap analysis and implement CAPAs for identified gaps
- Minimum of ten (10) years in Quality (QA, QC, QS, and/or Compliance) with progressive experience in a regulated cGMP industry
- Three (3) years' management experience
- Experience working within a GMP oral solid dosage manufacturing environment
- Contract development manufacturing experience is preferred
- Strong written, verbal, and interpersonal communication skills
- Strong proficiency with GxP electronic systems such as SAP, Trackwise, and Ensur (electronic document management system)
- Proficiency in MS Office
- High attention to detail
Piramal Group is a global healthcare company with a presence in over 100 countries. We are committed to delivering innovative solutions that improve patient outcomes and quality of life. Our values of integrity, innovation, and customer focus drive our business and guide our interactions with customers, partners, and employees.
We are an equal employment opportunity employer and welcome applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.
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