At our Dartford site (CMT) our mission is to be the industry choice for high potent, high value API micronization. Today, we supply ~40 micronized product to a wide range of customers and patients. We’re committed to a culture of continuous improvement and people development so everyone at the site can grow and thrive.
Catalent is currently recruiting for a Technical Author role is to assist the Catalent Dartford team with reviewing & rewriting site procedures, forms and standard work instructions. The successful person will spend time with each function to understand the purpose of each procedure and then update & simplifying that procedure and associated documents, in line with cGMP requirements and Catalent standards.
The successful person will manage the update of each document through EDMS, using the relevant department subject matter experts as technical reviewers. Progress will be reported to the SLT each week.
This position is a 1 Year FTC.
The role:
- Extensive experience of working in an API /Drug product manufacturing site and GMP environment – micronisation experience an advantage
- Ability to organise and prioritise work and display an accurate and systematic approach to work.
- Ability to be assertive to ensure appropriate GMP and business standards are achieved.
- Work unsupervised, be self-motivated and take the initiative to introduce new ideas.
- Must have good written and verbal communication skills.
- Must be able to make decisions in a timely manner.
- Honesty and integrity, with a positive attitude to work.
- Able to create and manage relationship cross-functionally
- Thorough knowledge of EU, US and other regulations relevant to Catalent pharmaceutical operations as well as a strong working knowledge of API manufacturing.
- High level of proficiency in computer skills, including word processing and spreadsheets
The candidate
- Experience working within a Pharmaceutical/ GMP environment essential
- Knowledge of GMP documentation.
- Able to work with minimum supervision and to a high standard
- Comfortable working collaboratively as part of a small team and also able to influence others
- Results orientated.
- Positive, flexible and approachable.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
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, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.
