What are the responsibilities and job description for the Supervisor Production Operations position at Aveva Drug Delivery Systems?
Description
Job Responsibilities:
Job Responsibilities:
- Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
- When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
- Performs daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
- Ensures Operators monitor and document the critical process parameters during the manufacturing process.
- Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues.
- Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
- Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision.
- Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals.
- Trains new employees for new positions, processes, and retrains others as necessary.
- Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks.
- Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
- Ensures housekeeping standards are followed and area is maintained during shift.
- Follows all departmental and company safety policies in order to prevent injury to self and others.
- Backfills associates in the processing rooms as needed.
- Trains and audits production employees to ensure current approved SOP’s are followed.
- Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
- Performs other duties in order to meet department's production schedule or to comply with cGMPs.
- Works as a member of the team to achieve all outcomes.
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
- Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.
- Works as a member of the team to achieve all outcomes.
- Education
- Batchelor’s Degree in Pharmaceutical Sciences, Engineering or closely allied life sciences discipline.
- Knowledge, Skills and Abilities
- Ability to lead by establishing and providing clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture.
- Ability to organize and distribute work appropriately in an environment requiring strict adherence to timelines.
- Demonstrates leadership experience particularly in the areas of approachability, dealing with direct reports, managing diversity, setting goals and objectives and measuring performance.
- Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions and experience in systematic problem solving.
- Capacity and tact to address performance of direct reports and provide constructive feedback in a firm and timely manner.
- Computer literacy with Microsoft office programs and exposure to JDE or other ERPs.
- Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.
- Excellent communication skills (written and spoken English) including strong verbal and interpersonal skills to lead and influence.
- Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
- Experience
- 4 years’ experience in a fast-paced, Lean Manufacturing environment required. Experience in a GMP environment preferred (pharmaceutical manufacturing/ biotechnology).
- 3 years experience in aseptic environments, sterile filling, or aseptic technique preferred.
- 3 years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred.
- Must be able to fluently read, write and speak in English.