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GSK India
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Process History Files Scientific Writer MSAT

Process History Files Scientific Writer MSAT

GSK India

10 - 16 years

35 - 40 Lacs

Bengaluru

Posted:15 hours ago| Platform:

Apply

Skills Required

Procurement Publishing SAP Scientific writing Pharma Analytical Pharmacy Oncology GMP Forecasting

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job responsibilities include some of the following: Product & Process Knowledge Management:

Data gathering ( Product Quality Review, Change Requests, Methods of Production, Genealogical tree and quality reporting, PHF Parking lot (document with the pending point of the previous version of PHF.
Manage PHF governance & operational follow up meetings: (kick off, consolidation, follow up )
Write/update the PHF s with information gathered and manage the approval process with identified stakeholders.
PHF Publishing in Veeva,
Manage AAR with stakeholders, PHF continuous improvement
Collaboration and Communication: Work collaboratively with various departments, including MSAT discipline experts, QA, GCC associates.
Documentation and right first time: Ensure the consistent quality of the PHF s.
Innovation: Identify opportunities for innovation based on scientific advancements and emerging trends ( IA, digitalization,
Training and Development: train staff and stakeholders on best knowledge management practices in close collaboration with MSAT information and knowledge management experts.
Checking that the PHF knowledge management strategy laid out by the Global MSAT Compliance and Knowledge Management Process Excellence lead is being respected.

Basic Qualifications:

Bachelor s Degree ideally with a Ph.D. in a relevant scientific discipline (e.g., biology, chemistry, pharmacy )
Experience: at least 10-16 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A working experience of at least 3+ years as a scientific writer or in a similar role is key asset. S takeholder engagement experience in an international and matrixial environment.
Advanced scientific writing skills and capabilities .
Strong communication, team management skills and interpersonal skills.
Strong attention to detail and ability to produce high-quality, accurate documents.
Uphold the highest standards of scientific integrity and ethics.
Analytical and problem-solving skills.
Strong knowledge and understanding of Pharmaceutical or Biopharmaceutical environment.
Knowledge and understanding of Good Manufacturing Practice (GMP).
Knowledge of regulatory requirements and industry standards.
Advanced Written and oral fluency in English.
Office tools:
Classical (word, excel, PowerPoint) and specific (Office Timeline Pro, pdf creator),
Documentum & SAP GSK Access (PHF, PQR, general R&D doc, Techshare, )
Veeva GSK Access .

Preferred Qualifications: MSAT, or Manufacturing Science and Technology, is a critical function within a pharmaceutical and biopharmaceutical manufacturing organization in general. The GSK MSAT team is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

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Process History Files Scientific Writer MSAT