Technical Services Manager
- Guayama, Puerto Rico
Site Name: Guayama JV
Posted Date: Oct 7 2020
As Technical Services Manager you will Oversee the operations, projects and initiatives of the Technical Services department. Drives the application of advanced technical process solutions in manufacturing, packaging and validation improvement, ensuring priorities align with customer needs, technology management objectives, company goals and government regulations. Oversees the transfer of technology from development to production with and/or between manufacturing sites. Oversees product, process and raw material changes. Oversees Investigation process for all Site deviations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Providing strategic direction and technical support to the Technical Services personnel. Subject Mater Expert (SME) from Technical Services area.
- Overviews Investigation Processes for deviations across all areas of the Site.
- Works through the Lead Investigator team to complete on time, effective investigations and identifies robust CAPA to eliminate repeat deviation.
- Setting and implementing the validation strategies for changes to the existing pharmaceutical process.
- Manage the Site Validation Master Plan (VMP)
- Identification and implementation of process improvements related to quality and process jointly with Operations area.
- Implementation of process-supplier changes & process improvements
- Maintenance and optimization through new strategies of the cleaning validation program
- Providing the Technical support to manufacturing areas for quality issues.
- Keep abreast on new technologies and or strategic initiatives from GSK Consumer business
- Meeting the Site Goals relevant to the Technical Support function and actively supporting all site metrics.
- Actively supporting readiness for Regulatory audits and meeting commitments from such audit
- Managing contracted services as required to meet department goals.
- Providing strategic direction and technical support to the Project Managers,
- and scientists from Technical Services area.
- Assess Site Capacity to Receive New Products jointly with Operations area
- Responsible to Integrate all Site functions to deliver on the New Product Introduction commitments
- Develops Validation Strategies for new consumer processes
- Overviews and ensures deadlines are met on Transfer of consumer products
- Identification & implementation of improvements in new process & products
- Effectively & Seamlessly Overviews the Coordination of Process Capability Lots
- Evaluate Process Capability Lots Data and ensure Specialists issues timely report to stakeholders.
- Actively participates in the review of regulatory registration either of new products or changes.
- Active participation in Regulatory inspections
- Active leadership & communication of project status with key stakeholders- PMs, R&D, Senior Mgt
- Keep abreast on new technology.
- Take measures to exclude from operations any person who might be a source of microbial contamination due to a health conditions following site procedures.
- Supervises overall sanitation practices and ensures personnel is trained in the sanitation procedures, which include washing hands thoroughly (and sanitizing if necessary, to protect against contamination with microorganisms) in an adequate hand-washing facility:
- Before starting work; and
- At any time when the hands may have become soiled or contaminated;
- Supervises and ensures personnel is trained in the processes to prevent contamination of components or products while performing manufacturing operations to avoid potential growth of microorganisms and the potential for contamination.
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in Pharmacy or Engineering
- 5 + years of experience in pharmaceutical industries plus supervisory experience or equivalent.
- Masters Degree in Pharmacy or Engineering
- PhD Pharmacy or Engineering
Why GSK? Our values and expectationsare 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:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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