The Line Manager provides day to day leadership and resources to assure proper practices for safety, quality and training are followed during the production process.
The Line Manager reports to the Value Stream Manager Manufacturing and Packaging. Union personnel assigned to the production department are direct reports to the Manufacturing Line Manager.
Primary responsibilities of this role include the following:
- Communicate short and long term plans and goals with Union staff
i. Act as the key resource for staff members to achieve all plans and goals
- Track staff attendance and administer corrective action
- Enforce high Operational standards (cGMPs, Safety, OSHA, DEA, Delivery, Cost)
- Identify and voice the removal of barriers to effectively execute the business plan
- Provide coaching and continuously monitor performance as well as provide feedback
- Manage performance reviews and citizenship assessment for staff
- Develops and implements initiatives to improve safety, quality, productivity and to reduce costs
- Ensure the safety of staff by practicing and enforcing safe practices and procedures
- Manages quality/GMP results and ensures proper paperwork is complete (Deviations, CAPAs, SOPs, MCAs, etc.)
- Responsible for productivity improvements after tracking equipment/people deficiencies
- Review and audit manufacturing and packaging records and documentation
- Write investigation reports and work with Quality to approve
- Develops Operations plans and measures team performance against goals.
- Ensure schedule adherence is met and if issue occur create recovery plans and meet customer deliveries
- Ensure required training is carried out and in line with Operations’ needs
- Identifies and improves training gaps
- College Degree (Scientific/Engineering) Preferred, or High School Diploma with 5 years of progressive demonstrated pharmaceutical operations experience.
- Solid Dose Manufacturing Experience.
- Demonstrates strong leadership, initiative and follow-through.
- Able to operate independently or as a team within a fast paced environment.
- Proven ability to set standards holds others accountable build organizational capability and set strategy to deliver business objectives.
- Excellent written and verbal communication.
- Can effectively prioritize work assignments and meet deadlines.
GMP DECISION-MAKING AUTHORITY
- Write, review and approve documents as required; i.e., deviation reports, purchase requisitions, new and revised batch record formulations, etc.
- Determine required technical training and champion resources which deliver against specific training plans.