Opening for the post of Senior Manager – Technical Operations @ Bayer
Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. The company’s products and services are designed to benefit people and improve their quality of life. At the same time Bayer creates value through innovation, growth and high earning power.
Post : Senior Manager – Technical Operations
- 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.
Candidate Profile :
Education : Graduate in Pharmacy / B.Tech
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
Education : B.Pharm/B.Tech
Experience : 8-12 years
Location : Thane
Functional Area: Technical Operations
Industry Type: Pharma/Biotech/Clinical Research
End Date: 28th November, 2016
If you are the person that fulfills the requirements above, please send your CV in English to e-mail: firstname.lastname@example.org