Posted By
HR
HR Team at Piramal Enterprises Limited
8167
JOB VIEWS
126
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0
RECRUITER ACTIONS
Posted in
SCM & Operations
Job Code
461355
Industry - Pharmaceuticals
Skills - cGMP
Job Type - Permanent
Description/PRIMARY RESPONSIBILITIES :
- Provide support and coordination for compliance and regulatory-related projects.
- Apply cGMP (Current Good Manufacturing Practice) concepts into validation and change control, supplier quality management, quality system documentation review, and Development and/or modification of quality systems and other cGMP processes.
- Create, prepare and review technical reports.
- Conduct internal and external/supplier audits.
- Perform activities supporting the supplier quality management program, including supplier evaluations, audits, vendor requests/inquiries, and supplier complaint follow-up.
- Interact with clients regarding compliance/regulatory issues.
- Maintain current knowledge base of existing and emerging regulations by developing cGMP/Compliance and/or Regulatory policies and training for staff.
- Conduct and/or annual product review activities.
- Coordinate, prepare and review regulatory filing submissions.
- Expected to cross-train in identified quality unit activities outside of the Compliance and Regulatory department in a supporting capacity.
QUALIFICATIONS
- Bachelor's degree in a scientific discipline or equivalent with 3+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment (sterile manufacturing (injectables) preferred).
- Technical writing experience is required.
- Working knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing.
- Experience with Supplier Quality Management programs and/or auditing is preferred.
- Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU. Other jurisdictions a plus.
- Must be a detail oriented team player with effective planning, analytical thinking, organization, and execution skills.
- Must have proficiency in the Microsoft Office Suite.
- Excellent communication skills with internal and external personnel is essential.
- Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines.
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.
Contact - Heather Humphreys
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Posted By
HR
HR Team at Piramal Enterprises Limited
8167
JOB VIEWS
126
APPLICATIONS
0
RECRUITER ACTIONS
Posted in
SCM & Operations
Job Code
461355