Position Overview Basic Functions & Responsibility
Essential function(s) includes, but is not limited to :
This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with our Manufacturing Division requirements and regulatory requirements and expectations.
Under his / her responsibilities fall the quality oversight for
The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Operations Manager) with regards to the above described activities.
The incumbent should lead a team of 4 to 5 members whom responsible for above activities at our site.
Primary activities include, but are not limited to :
1. Establish adequate controls and procedures for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labeling, drug substances incl.
intermediates and drug products incl. intermediates.
2. Ensure that adequate processes and procedures are in place and followed for material release
3. Lead investigations related to the section with collaboration of other departments as needed. Also generate deviation reports, perform trend analysis of root causes on a periodic basis.
4. Manage corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labeling, drug substances and drug products and associated facilities.
5. Perform Annual Product Reviews / Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
6. Represent quality, provide quality oversight in complex projects or initiatives such as new product introduction.
7. Lead the team for continuous improvement initiatives and be act as a change agent to initiate such activities.
8. Manage Quality and supply KPIs related to the section in aligned with site Hoshin.
9. Establish skill development schemes for the team, be a part of talent development for the team.
10.Manage daily activities, issues through standard processes such as Tier.
Skills (include specific skill levels required to apply our Company's Leadership Principles)
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
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Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status : Regular
Relocation : Domestic
VISA Sponsorship :
Travel Requirements :
No Travel Required
Flexible Work Arrangements :
Shift : Not Indicated
Valid Driving License :