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Manager | Job in Piramal | General Manager QA and Med-Regulatory | Latest job in Mumbai 2022
About Company
Piramal Group is a worldwide business combination with different interests in Pharma, Financial Services and Real Estate. The Group has workplaces in more than 30 nations and a worldwide brand presence in excess of 100 business sectors. Driven by Mr. Ajay Piramal, the Chairman, Piramal Group is a torchbearer of trusteeship and mindful business ethos. In light of the way of thinking of ‘Progressing admirably and Doing Good’, the Group keeps on making long haul an incentive for its partners and the local area on the loose. In the thirty years of its reality, Piramal Group has sought after a twin procedure of both natural and inorganic development.
Additional Information | Job in Piramal
| Job Profile | General Manager QA and Med-Regulatory |
| Experience | 15 years |
| Location | Mumbai |
Roles and Responsibilities | Job in Piramal
- Quality assurance
- Assisting Key Business Agenda
- Represent QA function at senior management and review meetings
- To support SCM in development of alternate vendors of RM and TP MFG sites
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implication of these changes
- Identify Business Risks w.r.t. quality systems, regulatory and compliance.
- To bring and review all products of CPD, under umbrella of QMS
- Provide monthly KPIs and status reports on project and compliance initiatives to management
- Take relevant measures to avoid cost of poor quality and control/reduce cost of conformance
- Ensure that the customer (internal & external) needs are understood properly and the products are delivered on time in full, from the quality function perspective aligned with regulatory compliance requirements
- Evaluate products/ MFG sites under Due Diligence Program
- Quality Adherence & Checks
- Overall supervising and reviewing of quality activities at the sites allocated
- Improve Existing Quality – Quality of Standard Test Protocols/ Specs/ process harmonization, tech transfers
- Maintain product quality by enforcing quality assurance policies, Review of systems for process documentation and enforcing regulatory requirements
- Training and Development
- Training internal and external stakeholders
- Lead, manage and ensure proper training to any relevant change management programs throughout the company.
- Share learnings from product launches/ tech transfers with CFT
- Medical & Regulatory Affairs
- Set up and drive business strategy and processes
- Develop and execute Med-Reg (Medical Regulatory) strategy and annual operating plan
- Develop tracking mechanisms to gather intelligence on medical and regulatory trends. Analyze and Disseminate this information to help further business strategy
- Developing SOP, specs, success KRAs and tracking of effectiveness / compliance of stakeholders to med regulatory norms
- Maintain agile, efficient and competent Med-Reg (Medical Regulatory) infrastructure
- Ensure compliance with regulations and SOP
- Actively network with industry peers and participate in policy making that impact Indian Regulations and thus business
- Ensure high scientific quality for marketing collaterals
- Aid in acquisition work with respect to due diligence
- Scientific support to Brand in developing claims and support
- Resolution of queries/complaints
- Aid in all resolution of all quality and regulatory-related matters with ensuring minimal impact to business sales and maximum compliance to regulation.
- People Management and Development
- Lead, recruit, grow and retain high-caliber talent to build competent teams.
- Empower team members to move across existing opportunities and take on responsibilities independently
Eligibility | Job in Piramal
- Person with 15 plus years of experience in quality with minimum 5 years in managing CMOs effectively.
- Who has knowledge working with branded and OTC products.
- Understand and interpret Indian FDA schedules, DCGI regulations and WHO standards well.
- Worked well in quality leadership position and had a good stakeholder management skills.
- Good and communications and presentations.
- Can balance compliance and business. Understand both while prioritizing patient safety and product quality.
- Who has sense of urgency and is result oriented.
- Can develop high performing and motivated team.
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