Bayer Group in India
Thane (West) – 400 607
Tel: +91 22 2531 3377
Bayer is a global enterprise with core competencies in the fields of health care, agriculture and high-tech polymer materials. As an innovation company, it sets trends in research-intensive areas. Bayer’s products and services are designed to benefit people and improve their quality of life.
Bayer Group in India offers its employees a wealth of excellent career opportunities both in India and around the world. As a modern employer, we take great care to ensure that our employees are able to balance career development opportunities with their personal life planning.
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Manager – Technical Operations
Location: Thane, (Maharashtra)
YOUR TASKS AND RESPONSIBILITIES:
- Plan & execute manufacturing requirement as per the sales forecast on monthly, quarterly and annual basis.
- To ensure timely delivery of finished goods as per agreed schedule from the contract manufacturing site by ensuring availability of Input materials.
- To ensure GMP, Regulatory & safety compliance at contract manufacturing site & Input material vendors by conducting QA audits / visits and adherence to agreed CAPA (Corrective Action and Preventive Action).
- Conduct Due Diligence audits of manufacturing sites and products for any inorganic growth options.
- To perform quality checks through random Sampling and analysis of the samples with the help of approved contract laboratory, review of APR(Annual product review), BMR (Batch Manufacturing Records), COA (Certificate of analysis) , Stability reports, Change control & Deviation records at TPM site.
- Perform Technological Transfer.-To organize and execute the analytical method validation / transfers, process validation of various dosage forms like tablets, external preparations, liquids and Parenterals preparations .
- Prepare and maintain Quality Assurance documentation like SOPs (Standard Operating Procedures), Input materials and finished products specifications & testing procedures, BMR (Batch Manufacturing Record), MFR (Master Formula Records), Packaging material Art works, PVP (Process Validation Protocol) & PVR (Process validation report), Conduct Analytical method validation / transfer, Deviation and Change control Application, Stability Protocol and Report , Market complaints investigations and CAPA.
- To educate and update the manufacturing sites on GMP and Bayer quality requirements.
- Negotiate and execute the terms of commercial and quality agreement with the contract manufacturer.
- Application and maintaining of manufacturing licenses from various state Drug authorities (FDA). Comply & submission of all regulatory requirements (post clinical) to the regulators.
- Design, approve, negotiate and procure product related change parts. Maintenance & upkeep of these change parts inventory at contract manufacturing locations.
- Education : Graduate in Pharmacy / B.Tech
Other Skill sets:
- Between 8-12 years of work experience in a reputed multi-product contract manufacturing organization or MNC having outsourced contract manufacturing activities.
- Strong communication skills, Interpersonal & cross functional team player
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