Piramal Enterprises Looking for Manager – Technical Support (QA & Validation) at Mumbai, Maharashtra Full Time

• To understand the business & product needs with respect to system establishment and sustainability. In the process, it requires interactions with different sites and also assessing complexities of current processes.
• Deputation at manufacturing sites as QA team member.
• Perform site QA routine activities, Validation Activities, internal audit / gap assessment as per FDA 6 system and DI (Data Integrity). Lead remediation plan and restore compliance metrics at site.
• Prepare risk papers, position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business sustenance and business continuity.
• Work across all disciplines to ensure that the site maintains a state of readiness for inspection by regulatory agencies.
• Effectively track actions identified for restoring compliance at identified sites. Resolve the red flags and raise alerts timely.
• Identify quality requirements by reviewing regulations, guidelines, and standards, including USFDA, EU GMP, ICH and ISO. Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the site / company.
• Represent Quality at senior management and review meetings.
• Responsible to follow the safety and environmental procedures deployed at Kurla office and sites.
• Coordinate with Corporate team for Corporate Initiatives and Long Term Quality Strategy.

Qualifications

QUALIFICATION: B. Pharm / M. Pharm

EXPERIENCE:

• Need to be ready to live and embrace the Piramal values
• Quality professional with 10+ years of experience in a regulated pharma companies
• Experience in API and Formulations. International Exposure
• Worked in USFDA, MHRA approved facility. Faced regulatory inspections
• Shall have good knowledge of QA operations
• Hands on experience implementing quality systems at site
• Well-organized, committed and result oriented professional, with strong verbal and written communication skills. Good Collaboration skills and Team player
• Passport is required. Candidates with valid US Visa preferred

Primary Location: India-Maharashtra-Mumbai

Work Locations: Kurla Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction, Near Phoenix Mall, Kurla (West) Mumbai 400070,,,,,,

Job: Quality Assurance

Organization: Pharma Solutions

Day Job

Job Posting: 01-Apr-2022, 11:19:56 AM