Be the First to Apply
Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Manager - Technical Support
Job Description
GMP compliance at PPL sites. Ensure implementation/remediation of the Quality systems, procedures and practices at the identified site(s) as per current regulations and organization expectations. To implement Corporate initiatives.
KEY STAKEHOLDERS: INTERNAL
Site Quality Team, Corporate Functions
KEY STAKEHOLDERS: EXTERNAL
Customers
Reporting Structure
Reports to Lead – Technical Support
Essential Qualification
Post-Graduate in Science/ B. Pharm/ M. Pharm or relevant technical qualification
Experience
- Expertise in Quality Assurance with experience in Formulations and API
- Sound exposure of QMS applications with experience of minimum 12 years in reputed Pharma companies
- Experience in QA and manufacturing operations.
- Worked in regulatory approved facility; experience of facing regulatory inspections.
- Strong verbal and written English communication skills.
- International exposure and a candidate with a US Visa preferred.
Key Roles/Responsibilities
- On-site/ virtual support to quality systems, compliance and remediation activities at manufacturing sites.
- Effectively track actions identified for restoring compliance at identified sites. Resolve the red flags and raise alerts timely.
- Generate risk papers, support investigations and mitigation plans for business sustenance and continuity.
- Keep abreast of changes to quality regulations and guidelines; generate the action plan and verify the compliance for patient safety, regulatory compliance, product quality and business implications.
- Responsible for following the safety and environmental procedures deployed at the Kurla office and sites.
- Corporate Initiatives: Execution of assigned corporate initiatives.
