Product Lifecycle Specialist

Haleon • Town of Durham, NY

1d • $79,000 - $130,351

About The Position

This role oversees the product lifecycle for the site, including the redaction of Periodic Product Reviews (PPRs) according to annual plans, site-wide review of change controls, oversight of stability programs, and management of complaints. The purpose is to identify areas for product improvement with stakeholders, investigate, and implement corrective and preventive actions (CAPA) in compliance with local regulatory and Quality requirements. It also aims to simplify and adapt processes for manufactured products to make compliance easier.

Requirements

• Bachelor’s Degree in Pharmacy, PharmD or Science related.
• More than eight (5) years of experience in a similar role

Nice To Haves

• Has basic general technical knowledge, and specific discipline knowledge.
• Have good verbal and written skills. Can articulate issues and solutions to the team. Can produce effective project reports and presentations.
• Can effectively interact and collaborate with team members. Demonstrates respect for others. Encourages team participation

Responsibilities

• Follow quality system and procedures for PPR in compliance with global Standard Operating Procedure requirements.
• Compile PPRs in line with the site’s procedures and established timelines.
• Collect data, perform review, and incorporate PPR data elements into the PPR reports as per the established PPR annual schedules/Plan.
• Retrieve data from VQMS and/or communicate with the pertinent site groups for all investigations, CAPA, and trending records pertaining to raw material, excipients, packaging components, finished product and stability acquired within the annual review period.
• Retrieve data from SAP and/or communicate with the pertinent site groups to determine the batches manufactured, packaged, or released during the annual review period, as well as the associated active and inactive ingredients utilized for the production process.
• Escalate any issues that may prevent that PPRs are completed in time and with the necessary quality to meet regulatory expectations and global internal requirements.
• Provide an overall assessment of PPR data elements and make recommendations when gaps or trends are identified; perform any data trending needed for the PPRs, where applicable.
• Perform peer review of PPRs written by other PPR Specialist Quality Technical writers.
• Identify any out of trend issues (lower Process Capability etc.) with a product with relevant functions (Technical, Stability, Production, Compliance, QA Operations, QS and QC department) to facilitate investigation and resolution of PPRs in Veeva QMS.
• Maintain and archive PPR reports and supporting documentation in VQDocs.
• Raise deviation and CAPA, if the technical gaps observed during PPR analysis.
• Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and Corporate Guidelines.

Benefits

• Competitive pay
• Comprehensive benefits program
• Generous 401(k) plan
• Tuition reimbursement
• Time off programs
• 6 months paid parental leave
• Healthcare programs (company pays for the majority of medical coverage for you and your family)
• Discretionary bonus based on achievement of key business performance
• Other incentive/recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior