Senior Manufacturing Compliance Specialist

Industry

Pharmaceuticals

Advert ID

FOX_BBBH58676

Location

Durham

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Raleigh Engineering - (USA) 701 Corporate Center Drive Suite 375 NC Raleigh , NC 27607

ContactNumber

919-755-5804

Job Description

Position Summary



* Represent the team in high level meetings and assume leader roles within the Manufacturing Compliance and Training Department.

* In preparation for PAI readiness and in support of Audits tours, Lead and Coordinate the Manufacturing and Facilities Walkthrough Program. Identify a list of possible observations, update the Walkthrough Program Tracker and perform the corresponding follow up with area owners.

* Lead, provide guidance and support to Manufacturing Compliance Specialist.

* Provides training for investigative staff and aids in their professional development; explains existing policies and procedures.

* Identifies issues and concerns from the investigations, leading to recommendations for review and improvement of policies, procedures, training and/or equipment.

* Lead, manage or participate in critical investigations. May represent Manufacturing Compliance and Training Management in meetings and other forums if needed.

* Provide additional administrative support to Manufacturing Compliance and Training Management.

* As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations.



* The investigator will conduct and drive closure of non-conformance events to identify root cause, product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements.

* Analyze existing deviations and a potential deviation focusing on establishes effective corrective and preventive actions to minimize the reoccurrence of the event.

* Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.

* Complete investigations and CAPAs in alignment with established procedures and timelines



Position Responsibility



* Gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. Analyze existing and potential content, focusing on reuse and single-sourcing opportunities.

* Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.

* Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.







Minimum Requirements



* BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; more than 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering.

* Must be able to interface positively with Regulatory Agencies, customers, and company departments.



* Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before internal groups or employees of organization. Good deductive and inductive critical thinking skills required.