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Product Steward (Pharma)

Start: **ASAP**

Contract Length: **8 months to start, possible to extend**

Pay: **$43.00 - $65.00 per hour (depending on experience)**

Responsible for educating themselves regarding process knowledge of the product(s) assigned to the site and helping assist management of the products throughout the commercial lifecycle, assists the team in maintaining the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.

Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.

Stewardship– for the product(s) assigned:

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the

entire commercial lifecycle, since transfer from development to date, act as SPOC.

• Create and maintain a product specific Quality Risk Analysis (QRAs).

• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular

product specific data trending.

• Review APQR and decide on state of control.

• Ensure inspection readiness for all process related aspects of assigned products.

• Track and evaluate product performance, trending, detect issues, implementation of CAPAs.

• Lead / support root cause investigation of process failures, initiate and lead product improvement projects,

involving cross-functional teams.

• Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in

each laboratory (transfer of the product-specific QRA).

• Ensure data and trending are visible and communicated at shop floor level.

• Present product performance and status of product improvement projects in site Manufacturing Robustness

Review Board (MRRB).

• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical

batches, challenge technical risk and business benefit of technical changes proposed.

• Ensure creation of Master Batch Record.

• Contribute to registration strategy and support registration activities.

Validation – for the product(s) assigned:

• Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).

• Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.

• Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place,

support improving the control strategy where applicable.

• Review / update QRA prior to validation for technical changes.

• Approve validation protocol and report related to technical changes.

• Provide all necessary information to perform the validation documentation, align with stability experts and QC

labs to organize the stability samples.

• Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.

Launch & Transfer– for the product(s) assigned:

• Provide the necessary data for the technical activities involved in transferring out a product, focusing on

existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

Manufacturing Excellence– for the product(s) assigned:

• Design and manage optimization projects.

• Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness

and sustainability.

• Collaborate with OPEX for product / process improvements.

Training:

• Own the Training Curriculum for own Job Profile.

COMPANY Manufacturing Manual:

• Support implementation of COMPANY Manufacturing Manual principle 3.

• Represent site in product stewardship network.

Key Performance Indicators (Indicate how performance for this role will be measured)

• Product is maintained in constant state of validation.

• Product history is documented and available and current since transfer from development to date.

• Recurring Deviations.

• Ppk/CpK – process capability.

• OoS, OoE – Out of Specification, Out of Expectation – process-related.

• Customer Complaints – process-related.

• Recalls – process-related.

• Success rate of Health Authorities’ inspections.

• Completeness of Regulatory CMC dossier.

• Effective CAPA.

• Continuously improving Yield.

• Technical reports executed on time and according to expectations

Education (minimum/desirable):

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.

• Desirable MSc. or equivalent experience.

**Languages:** Fluent in English and proficient in site local language.

Relevant Experiences:

• Minimum 8 year experience in process support, e.g. Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC.

• Proven process understanding (Pharma, GMP, Regulatory aspects).

• Sound experience of data handling and applied statistics is a must.

**Pay Details:** $43.00 to $67.86 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance