Pfizer
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Job Title: Senior Executive
Job Description:
Documentation
- Ensuring Compliance of Internal Procedures with Regulatory Guideline and cGMP regulations.
- Participates in Response Development to Regulatory Inspection Observations and Execute corrective actions recommended as a part of cGMP/Regulatory compliance
- Initiating and Reviewing of Change Control Related to Manufacturing Activities.
- Review of master documents related to productions.
- Participates on cGMP self inspection compliance audit and identify cGMP compliance gaps.
- Maintaining a control documents like SOP, SCI, SOI, BOMQ, PSS, Guidelines, Drawings, Preventive maintenance records of production etc.
- Ensure effective, safety, systems, are followed.
- To verify online documentations
- To ensure that calibrated equipments, Instruments, are used in manufacturing operations.
- Participating in performance verification study of equipments used in manufacturing.
- Check up for upkeep of facilities.
- Receipt of batch production records from production planning department
Prodcution
- Responsible for activities of all production units.
- Planning & execution of manufacturing and packing operations as per the time-line specified.
- Address problems that occurs during production, including problems with product, raw materials & equipment
- To serve as mentor for employees and arrange for training as when it is required
- Ensure compliance to systems and written procedures.
- Coordinating and assisting in recruitment of personnel pertaining to production department.
- Improvement and innovation on the processes to ensure smooth & contamination free products.
- Co- Ordination with inter related departments like QC, QA, Validation, Engineering etc for trouble free Operations.
- Training the plant personnel with respect to production related activities in compliance to regulatory bodies.
- Ensuring online documentation and complying to the internal audit observations.
- Ensure effective safety systems are implemented in the premises.
- Responsible for continuous improvements with respect to quality & productivity.
- Planning and execution of manufacturing and packaging operations as per the time-lines specified.
- Ensure the compliance to systems and written procedures.
- Co-ordinating and assisting in Recruitment of personal pertaining to production department.
- Approval of written procedure/validation protocols/ MMR and MPR etc.
- Improvement and innovation on the process to ensure smooth and contamination free products.
- Co-ordination with inter-related departments like QC, QA, Validation, Engineering etc., for trouble free operations.
- Training the plant personals with respect to production related activities in compliance to CFR.
- Design and procurement of any process and packaging equipments.
- Ensuring online documentation and complying to the internal audit observation.
