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About the Role
Oversight of the product lifecycle for the site, including the redaction of Periodic Product Reviews, site-wide review of change controls, oversight of stability programs, and management of complaints. This role also identifies areas for product improvement and process simplification to enhance compliance.
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 PPR reports as per established PPR annual schedules/Plan.
- Retrieve data from VQMS and/or communicate with pertinent site groups for 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 pertinent site groups to determine batches manufactured, packaged, or released during the annual review period, as well as associated active and inactive ingredients utilized for the production process.
- Escalate any issues that may prevent PPRs from being completed on 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 data trending needed for PPRs, where applicable.
- Perform peer review of PPRs written by other PPR Specialist Quality Technical writers.
- Identify out-of-trend issues (e.g., lower Process Capability) with relevant functions 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 technical gaps are observed during PPR analysis.
- Comply with and ensure compliance to GMP, Quality, and other related policies, guidelines, and requirements as applicable by law and Corporate Guidelines.
Requirements
- Bachelor’s Degree in Pharmacy, PharmD or Science related.
- More than five (5) years of experience in a similar role.
- Basic general technical knowledge and specific discipline knowledge.
- Good verbal and written skills.
- Ability to articulate issues and solutions to the team.
- Ability to produce effective project reports and presentations.
- Ability to effectively interact and collaborate with team members.
- Demonstrates respect for others.
- Encourages team participation.
Experience Level
- More than five (5) years of experience
Education Level
- Bachelor’s Degree in Pharmacy, PharmD or Science related
Salary/Compensations
- $79,000 to $130,351.11 plus an 8% Performance Bonus
Benefits
- Generous 401(k) plan
- Tuition reimbursement
- Time off programs
- 6 months paid parental leave
- Healthcare programs where the company pays for the majority of your medical coverage for you and your family
- Discretionary bonus based on achievement of key business performance
- Other incentive/recognition programs
About the Company
- Haleon is a purpose-driven, world-class consumer company putting everyday health in the hands of millions.
- Our trusted portfolio of brands includes Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®.
- We have a unique blend of deep human understanding and trusted science.
- Our Win as One strategy puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do.
- We have an agile, performance-focused culture.
Equal Opportunity
- Haleon is committed to mobilizing our purpose in a way that represents the diverse consumers and communities who rely on our brands every day.
- We strive to create an inclusive culture where different backgrounds and views are valued and respected.
- We aim for Haleon to be a place where all employees feel they truly belong.
- Personal information provided during the application process is voluntary and used to meet regulatory and reporting obligations and support inclusion and belonging programs.
- Personal information will be kept confidential, used only for legitimate business purposes, and will never be used in making employment decisions.
- Haleon may be required to capture and report expenses incurred for US Licensed Healthcare Professionals or Healthcare Professionals as defined by the laws of the state issuing their license, in the event they are afforded an interview for employment, to ensure compliance with US Transparency requirements.
- If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact HR.AmericasSC-CS@haleon.com with the subject line ‘Haleon Careers: Job Accommodation Request’, including your name, contact information, Requisition ID, Job Title, Location, and a description of the accommodation requested.