Director- Operations (Senior Principal Scientist)
- Responsible for supervising daily operations including Manufacturing (including raw materials and finished product warehouses), Development activities and preformulation activities and reporting back to VP of PDS for any issues
- Direct and guide operations in GMP areas to ensure compliance to GMP requirements
- Ensure through daily supervision that the Compliance norms of the company are adhered to
- Ensure that the EHS norms of the company are adhered to and educate and guide the Formulation/ Preformulation Directors in case of issues faced by them
- Co-ordinate with Director of Support group to ensure that the facility and related equipment required for operations are optimally used at all times. In case of issues with facility/ equipment, working with Director of support group to ensure that these are resolved in time.
- Supervise warehouses for both raw materials ( including API’s excipients and packaging materials) and finished products and guide warehouse personnel in appropriate handling of ERP systems handling
- Co-ordination of work activities from PDS necessary for ensuring compliance to customer sand regulatory requirements from audits.
- Co-ordination with QA to close out all operations and procedure related issues arising from customer/ regulatory audits.
Scope of the job
- Be expected to perform the assigned job functions independently with limited supervision from upper management.
- Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
- Individuals will be expected to accomplish their work assignments by interacting closely with peers and by developing cooperative working relationships with other personnel inside the company; communicate effectively with customers when needed and instructed.
- Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams
Core business/Functional skills and education
- MS or Ph.D. degree in Pharmaceutics or other directly-related science discipline with hands –on experience in finished dosage form GMP manufacturing
- Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
- Prior experience in working in GMP environment is a must and experience in working in pilot plants with multiple products is preferred.
- Experience in handling ERP systems for production and warehouse control.
- Must be able to work in a team-oriented manner in order to accomplish performance objectives.
- Problem solving ability and adept guidance of formulation teams is also required.
- Strong technical expertise in formulation development and CT manufacturing
- Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements. A bilingual person ( Chinese and English) is preferable.
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