Product Lifecycle Specialist

About the role

Oversight of the product lifecycle for the site. This includes the redaction of Periodic Product Review as per annual plans, site-wide review of change controls, oversight of stability programs and management of complaints for the site. The purpose of this role is also to identify areas of product improvement with relevant stakeholders for necessary investigation and implementation of associated CAPA in compliance with local regulatory & Quality requirement.

And areas where our processes can be simplified and adapted the type of product manufactured, with an objective to make compliance easier

• 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.

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

• 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

The salary range for this position is from $79,000 to  plus an 8% Performance Bonus.

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.

We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Haleon are committed to mobilising our purpose…