Purpose of the Position

Reporting to the Plant Manager , the primary role and tasks for the Production Compliance Specialist is to perform and coordinate all aspects of investigations of production/manufacturing related incidents and deviations to ensure compliance with pharmaceutical products manufacturing and cGMP. A detail-oriented individual will conduct root cause investigations, close deviations on time, support assignment of proper corrective actions, and facilitate the implementation of corrective actions for manufacturing and operating processes. Using a hands-on approach, the specialist actively executes the deviation investigations, effective and efficient investigation writing, corrective and preventive actions development & implementation with production and supporting stakeholders. The Specialist will work closely with all in compliance with current FDA regulations, as well as awareness of other countries regulatory obligations, cGMP and GDP practices. Participation in Regulatory Agency inspections/activities required as needed

Key Role Specific Requirements

Deviation Investigations & Writing

• Work hands on with production and quality, on the manufacturing floor to collect and collate all required information, data and facts at the point of issue and deviation occurrence.
• Meet and exceed performance and deliverable expectations of completing investigations and writing investigations on time as laid out by the plant manager.
• Review batch documentation, testing results, training records, calibration records, policies, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents to support the deviation investigations and writing.
• Lead the investigation closure of manufacturing compliance-related documents using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance on time.
• Write deviations investigations using the right writing and compliance practices. Writing should be SMART – Specific & Situational, Measurable & Methodical, Actionable & Accurate, Realistic and Timely.

Continuous Improvement

• Engages and performs deviation investigations process by understanding the current state of process, sequence of flow, breaking down the problem into what, where, when, who, how: determines the point of cause, analyses and determines the real root causes by using various problem-solving tools – Cause and Effect, 6M -Fishbone Analysis, 5 Whys, Pareto and Graphical Analysis, Process Capability Methods; and Right Countermeasure Development.
• Use A3-8 Step problem solving methodologies to facilitate investigations. Work with production and supportive stakeholders to determine possible countermeasures for CAPAs.
• Identify and implement process improvements to drive success in the areas of quality, compliance, throughput flow, workplace safety, cost-effectiveness, and product lead time through CAPAs

Training

• Deliver training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs, EHS regulations and any other CAPA improvements related training.
• Keep current with new guidelines and Health Canada and FDA inspectional and scientific trends; and adjust CAPA procedures appropriately.
• Work with management team to improve the quality of the process and the procedures.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

BUILDING RELATIONSHIPS – is the process of developing social connections. This is a fundamental business competency that is the basis for reputation, influencing, closing deals and sustaining business relationships.

FOSTERING COLLABORATION/TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

Essential Requirements

• Prior experience in a pharmaceutical manufacturing environment required; understanding of Quality practices
• Training and knowledge of Good Manufacturing Practice regulations and standards
• Bachelor’s Degree in Life Sciences Microbiology or equivalent degree/diploma required
• Direct knowledge of cGMP regulations
• Able to develop, review and maintain metrics and quality audits
• Investigations experience in sterile manufacturing, filling & packaging environment
• Prior experience in Fishbone Investigation Procedure and A3 problem solving technique

Desirable:

• Prior experience in a Quality role preferred

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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