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-QA / Production
Job Description:
MANUFACTURING and SUPPLY:
- Act as Bayer Technical Operations (production and Quality) representative while dealing with management of contract manufacturer.
- Ensure un-interrupted Supply of Finished Goods meeting quality standards within budgeted cost.
- Perform supply risk assessments and monitor the mitigation plan to avoid stock out situations.
- Shooting the trouble at Contract Manufacturing sites related to Production, Quality and Input material vendors etc.
- Participate in negotiation of commercial agreement & cost with the contract manufacturer along with Head Technical Operations & Procurement.
- Packaging material artwork preparation, review & revision. Maintenance & upkeep of change parts inventory at contract manufacturing locations.
- Adhere to the directives and the guidelines issued by BHC-AG and statutory authorities pertaining to manufacturing site on SHEQ & GMP.
QUALITY ASSURANCE:
- Perform GMP/GDP audits at contractors/CFAs/Input material vendors / new opportunities to ensure GMP, Regulatory & Safety compliance at these sites. b) Support LQR (Local Quality Representative) for Bayer Business (Pharma, DC & RI) for India, Nepal, Bangladesh & Srilanka.
- Negotiate and execute the terms of quality agreement with the contract manufacturer. Maintain all Quality Agreement in valid state.
- Ensures Quality Oversight and compliance on to the Distribution function involving 4-5 CFAs on All India basis.
- Ensure mandatory compendial / Pharmacopoeia compliance of input materials and finished products.
- Assess deviations in production and quality control and follow-up CAPAs.
- 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 Technology Transfer - To organize and execute the analytical method validation / transfers, process validation of various dosage forms like tablets, external preparations, liquids and Parenteral preparations .
- Maintain & update databases like Track Wise, Promat, Bay4S, Dev@com, BASICS etc. for generation, maintenance and retrieval of technical and commercial data.
- 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.
- Review and check applicability of global directives and wherever required write local SOPs and Quality Assurance documentation (SOPs, technical dossiers).
- Handling & interaction on customer complaints and queries with customers.
- Perform assessment of new vendor requests & qualify the same. o) Seek Global QA approval for Repackaging operations prescribed under the Directives.
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REGULATORY:
a) Ensure that Drug licenses issued by state drug authorities (sFDA) are in valid state.
b) Obtain Certificates like COPP, WHO GMP Certificate, no-conviction certificate etc. from State Drug Authorities for the institutional business.
c) Obtain revised product permission from State Drug Authorities in case of compendial / Pharmacopoeial amendments of finished product label claim.
d) Provide technical support for the analysis of imported products by Authorities or the samples drawn by ADC customs.
Assigned Projects or initiatives:
a) Perform the assigned task (Product and Manufacturing site evaluation) related to new product introduction in agreed timeframe.
b) Seek approval from respective Global stake holders.
c) Participate in audits of Bayer Pharma AG Audit & support function, Regional Sites Co-ordination in qualification of global suppliers.
Candidate Profile :
1) Basic Education: B. Pharm
2)Minimum 8-10 years in Pharma industry of which minimum 2 year in contract manufacturing and QA.
Additional Information:
Education : B.Pharm
Experience : 8-10 years
Location : Thane
Functional Area: QA/Production
Industry Type: Pharma/Biotech/Clinical Research
End Date: 28th August, 2016
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