Compliance Manager

Catalent Pharma Solutions
Unspecified DOE
11 Oct 2016
25 Oct 2016
Compliance manager required at the Catalent Bolton facility. To co-ordinate the Compliance function ensuring that quality standards and business needs are met. Support the Quality function, as necessary, in the undertaking of general duties, ensuring adherence to the Quality philosophy and the delivery of customer service targets. To manage Quality In Production (warehouse) operators to ensure incoming inspection of starting materials (including bulk, intermediate and finished goods), primary, secondary and printed packaging materials meet with, customer, company and regulatory expectations. To perform Quality review of validation/qualification projects and activities in relation to: Qualification of packaging equipment. Cleaning validation. Process validation. Validation of IT systems where there is GMP bias. Support facilities-validation activities. Specific Duties, Activities, and Responsibilities: Develop systems related directly to quality within the Bolton production environment to maximise quality and efficiency and ensure compliance with current regulations for all medicinal products managed/packed by the facility. Monitor the performance and potential of the QIP (Warehouse) team and provide the direction and motivation necessary to secure optimum commitment and competence. As a subject matter expert, assist with departmental training and completion of training documentation. Generate or assist in the generation, review or approval of Standard Operating Procedures, Corporate Policy Statements and other defined critical documentation concerning validation. Assist in the conduct of customer and regulatory audits and the resolution of any audit deficiencies in a timely manner. Organise and participate in internal training sessions and co-ordinate training requirements with respect to validation/qualification systems, documentation and related deliverables. Act as the key customer contact, for designated customers, on all aspects of quality and quality related issues. Plan and ensure the efficient sampling of materials for analytical and release purposes. Contribute to the continuous development and improvement of relevant Quality systems, processes and procedures. Enforce compliance within the Bolton facility by ensuring staff consistently follow all compliance related procedures and by performing or ensuring the necessary investigations as and when deviations occur. Collate data on relevant aspects of the Quality function for incorporation into periodic reports. Preparation and regular review of Standard Operating Procedures relating to own areas of responsibility. Monitor regulatory and corporate requirements and assist in ensuring the site adapts to any changes. Enforce compliance within the Bolton facility by ensuring staff consistently follow all compliance related procedures and by performing or ensuring the necessary investigations as and when deviations occur. Provide support to the site EHS function including participating in onboarding and other processes. Ensure the management of systems for the recording, investigation and response to deviations, customer quality complaints and product recalls. Provide Quality subject matter expert support on deviations, complaints and change controls within the incoming area ensuring proper root cause analysis, impact assessment and CAPA. Qualifications Graduate or relevant experience within Pharmaceutical Quality/GMP environment. Preferable knowledge areas of key quality systems include non-conformance reporting, complaints, auditing/inspection. Knowledge/Skills Requirements: Ability to drive issues through to satisfactory conclusion. Ability to communicate effectively through verbal and written media. Ability to interact with personnel of all levels, including customers. Interpersonal, influencing, and listening skills. Organised approach with keen attention to detail. About Catalent Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. More products. Better treatments. Reliably supplied.™ Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobscatalent This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. This job was originally posted as