Our client, established in the year 1986, is the world’s second largest Integrated manufacturer of Ephedrine and Pseudo ephedrine salts. Our client's manufacturing facility at Mahad has been audited and approved by the Australian TGA, and the USFDA.
Post : QC Manager
Job Description:
• Oversee department operations, assuring that department is properly staffed, trained and supplied.
• Ensuring that the required initial and continuing training of his department personnel is carried out and adapted according to need.
• The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
• Ensuring that all necessary testing is carried out and the associated records evaluated;
• Approve specifications, sampling instructions, test methods and other Quality Control procedures;
• Ensuring the qualification and maintenance of his department, premises and equipment;
• Ensuring that the appropriate validations are done;
• Responsible for SOPs, change controls, deviations and CAPAs related to QC.
• Ensure and monitor adherence to all company policies and procedures relating to cGMP and GDP, SOPs and Health, Safety and Environmental Protection.
• Serve as key technical advisor/resource for the site, and ensure QC staff is appropriately trained to support plant operations, ensuring risks are identified and resolved.
• Participate in internal and regulatory agency audits.
• Conduct briefings and technical meetings for top management and representatives of process performance, product quality and of the quality management system and advocating continual improvement.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Candidate Profile
• M.S. in Pharmaceutical Sciences, Analytical Chemistry, Chemistry, microbiology or equivalent
• 8+ years of QC management experience in a pharmaceutical company, preferentially with parenterals and in global generic pharmaceutical companies.
• Experience in developing SOPs, protocols and technical documents.
• Experience in chemical and microbiological analysis of raw materials as well as finished products.
• Experienced in auditing and authority inspections
• Experience with validation and qualification of process equipment incl. lyophilizers, HVAC, PW and WFI generation, storage and distribution system.
• Experience with electronic systems such as LIMS, SAP and TrackWise is a plus.
• Ability to effectively communicate technical information in a clear, concise English language (written and verbal) within a GMP/GDP-regulated environment
Additional Information:
Experience: 8-10 yrs in Pharma
Location: Murbad (Kalyan Dist.), Maharashtra
Functional area: API bulk drugs
CTC: Rs. 8 to 10 lacs per annum
kindly write to us along with your CV at aspsol.recruitments@gmail.com, also mention your current/expected CTC, notice period
Posted by,
Reema Nambiar
Aspiring-Solutions hiring for its pharma client
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